xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05974618</url>
    </required_header>
    <id_info>
      <org_study_id>S66455</org_study_id>
      <nct_id>NCT05974618</nct_id>
    </id_info>
    <brief_title>Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA)</brief_title>
    <acronym>pIOTA</acronym>
    <official_title>Prospective Validation of the ADNEX Model for Discrimination Between Benign and Malignant Adnexal Masses in Pregnancy: the International Ovarian Tumour Analysis in Pregnancy Study (p-IOTA).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitaire Ziekenhuizen KU Leuven</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitaire Ziekenhuizen KU Leuven</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Prospective Validation of the ADNEX Model for discrimination between benign and malignant&#xD;
        adnexal masses in pregnancy:&#xD;
  &#xD;
        International Ovarian Tumour Analysis in pregnancy study (p-IOTA)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. STUDY SUMMARY&#xD;
  &#xD;
        TITLE Prospective Validation of the ADNEX Model for discrimination between benign and&#xD;
        malignant adnexal masses in pregnancy: the International Ovarian Tumour Analysis in pregnancy&#xD;
        study (p-IOTA).&#xD;
  &#xD;
        DESIGN Multicentre, prospective cohort observational study.&#xD;
  &#xD;
        BACKGROUND Adnexal masses are a common incidental finding in pregnancy. Whilst the majority&#xD;
        are benign and resolve spontaneously, a proportion can exhibit suspicious features during&#xD;
        pregnancy raising concern about an underlying malignancy. Correct classification of adnexal&#xD;
        masses is particularly important during pregnancy given the potential foetal and maternal&#xD;
        risks associated with surgical intervention. International Ovarian Tumour Analysis (IOTA)&#xD;
        group have developed robust, ultrasound-based tools, including the ADNEX model to support the&#xD;
        classification of adnexal masses. Ultrasound-based tools such the Modified Benign Simple&#xD;
        Descriptors and ADNEX have been externally validated to aid in the classification of adnexal&#xD;
        masses in non-pregnant women, but their use as a robust diagnostic tool in pregnancy remains&#xD;
        to be demonstrated.&#xD;
  &#xD;
        AIMS The principal objective of this study is to prospectively investigate the ability of the&#xD;
        ADNEX Model and a 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX)&#xD;
        to correctly discriminate between benign and malignant adnexal masses diagnosed in pregnancy.&#xD;
  &#xD;
        PRIMARY OUTCOME MEASURE False discovery rate (number of benign masses / number of masses&#xD;
        classified as malignant) when using the ADNEX Model to discriminate between benign and&#xD;
        malignant adnexal masses at 11-14 gestational weeks in pregnancy.&#xD;
  &#xD;
        ELIGIBILITY All women 18 years old and above with an adnexal mass found on ultrasound scan&#xD;
        during pregnancy - irrespective of whether the mass known before pregnancy OR diagnosed for&#xD;
        the first time on ultrasound scan during pregnancy.&#xD;
  &#xD;
        DURATION This study will be conducted over a minimum period of three years.&#xD;
  &#xD;
        KEYWORDS IOTA, ovarian mass, benign, malignant, ultrasound, pregnancy, post-partum&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 5, 2023</start_date>
    <completion_date type="Anticipated">July 2026</completion_date>
    <primary_completion_date type="Anticipated">July 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>1 Year</target_duration>
    <primary_outcome>
      <measure>- Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>- Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>- Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>- Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>- Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>- Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>C-index</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Sensitivity, Specificity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Calibration)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Clinical utility) Net benefit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(C-index)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Sensitivity, Specificity)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Calibration)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Clinical utility) Net benefit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>- Estimation of the ability of the ADNEX model and the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time po</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>- Estimation of the ability of the ADNEX model and the 2-step strategy (sensitivity, specificity, C-index, calibration intercept, calibration slope, clinical utility) to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment;</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment;</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of change throughout pregnancy and postpartum in papillations based on subjective assessment.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>Number, size (mm), colour score (1-4), and morphology.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in the ultrasound appearance of endometriomas during gestation;</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>Change in the ultrasound appearance of endometriomas during gestation;</description>
    </other_outcome>
    <other_outcome>
      <measure>- Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>- Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).</description>
    </other_outcome>
    <other_outcome>
      <measure>- Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125.</measure>
      <time_frame>outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)</time_frame>
      <description>(Specificity, Sensitivity, C-index, Calibration, Clinical Utility)</description>
    </other_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">1000</enrollment>
    <condition>Adnexal Mass</condition>
    <condition>Adnexal Tumor</condition>
    <condition>Adnexal Cyst</condition>
    <condition>Pregnancy Related</condition>
    <arm_group>
      <arm_group_label>First arm (primary objective):</arm_group_label>
      <description>First arm (primary objective): Adnexal mass scanned at 11-14 weeks. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. In addition, the patient will be asked to enter into the third arm of the study (see below) knowing that she can opt out from that arm at any point. If she consents to participate in the third arm, she will participate in a series of longitudinal examinations as described for the third arm.&#xD;
  All patients with a mass detected before 11 weeks will also be scanned at 11-14 weeks and can enter all three arms of the study. In this scenario, if more than one scan is performed during pregnancy before 11 weeks, only the first of several scans before 11 weeks will be included for the second and third arms of the study.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Second arm (secondary objective):</arm_group_label>
      <description>Second arm (secondary objective): Adnexal mass is seen for the first time during that pregnancy at any gestation. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. For patients with a mass detected before 11 weeks, see also above (they will be re-scanned at both 11-14 weeks and at 0-90 days postpartum).&#xD;
  In addition, the patient will be asked to enter into the third arm of the study knowing that she can opt out from that arm at any point. If she consents to this, she will participate in a series of longitudinal examinations as described for the third arm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Third arm (secondary objective):</arm_group_label>
      <description>Third arm (secondary objective): Patients from the first and second arms who agree to enrol into the third arm i.e. longitudinal examination of an adnexal mass during pregnancy. For the purposes of the longitudinal evaluation, the time points for the ultrasound examination are:&#xD;
  initial presenting scan if &lt;11 weeks;&#xD;
  11-14 weeks;&#xD;
  16 week scan - endometriomas ONLY;&#xD;
  second trimester routine scan (18-22 weeks);&#xD;
  30-34 weeks;&#xD;
  any additional scans during pregnancy which resulted in either conservative management with extra scans or surgical intervention (with reason for the extra scan or for surgery documented);&#xD;
  0-90 days postpartum.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Ultrasound</intervention_name>
      <description>A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and &quot;priority&quot; (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.</description>
      <arm_group_label>First arm (primary objective):</arm_group_label>
      <arm_group_label>Second arm (secondary objective):</arm_group_label>
      <arm_group_label>Third arm (secondary objective):</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Our sample population will come from Early Pregnancy Units and from Tertiary referral&#xD;
          centres for ultrasound with or without an oncology department attached to it. The sample&#xD;
          size estimation is based on data from Tertiary referral centres.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Consecutive patients with non-physiological adnexal masses or physiological cysts&#xD;
               measuring 5cm or more in largest dimension;&#xD;
  &#xD;
                 -  In case of more than one mass seen, only most suspicious mass to be included OR&#xD;
                    in case of two similar masses, the one with the largest dimension or most easily&#xD;
                    accessible with ultrasound;&#xD;
  &#xD;
                 -  Previously recruited patient presenting with a different mass in subsequent&#xD;
                    pregnancy;&#xD;
  &#xD;
                 -  Age 18 years and above.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Cysts deemed to be clearly physiological WHEN smaller than 5 cm (largest diameter);&#xD;
  &#xD;
                 -  Non-adnexal masses, e.g. peritoneal inclusion cysts (when diagnosis is certain)&#xD;
                    and peritoneal carcinomatosis with no adnexal mass;&#xD;
  &#xD;
                 -  The denial or withdrawal of written informed consent;&#xD;
  &#xD;
                 -  Same cyst already recruited for p-IOTA in a previous pregnancy.&#xD;
  &#xD;
                 -  Age &lt; 18 years&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Dirk Timmerman, Professor</last_name>
      <phone>+3216344201</phone>
      <email>dirk.timmerman@uzleuven.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Wouter Froyman, Professor</last_name>
      <phone>+3216344201</phone>
      <email>wouter.froyman@uzleuven.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UZ Leuven</name>
        <address>
          <city>Leuven</city>
          <state>Vlaams-Brabant</state>
          <zip>3000</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Dirk Timmerman, Professor</last_name>
        <phone>+3216344201</phone>
        <email>dirk.timmerman@uzleuven.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
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    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>IOTA</keyword>
    <keyword>ovarian mass</keyword>
    <keyword>pregnancy</keyword>
    <keyword>ultrasound</keyword>
    <keyword>post-partum</keyword>
    <keyword>benign</keyword>
    <keyword>malignant</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>January 30, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT05974618/Prot_000.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 20, 2022</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/18/NCT05974618/ICF_001.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05974618
  org study id: S66455
  nct id: NCT05974618
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Prospective Validation of the ADNEX Model for discrimination between benign and malignant
        adnexal masses in pregnancy:
  
        International Ovarian Tumour Analysis in pregnancy study (p-IOTA)
  1. STUDY SUMMARY
  
        TITLE Prospective Validation of the ADNEX Model for discrimination between benign and
        malignant adnexal masses in pregnancy: the International Ovarian Tumour Analysis in pregnancy
        study (p-IOTA).
  
        DESIGN Multicentre, prospective cohort observational study.
  
        BACKGROUND Adnexal masses are a common incidental finding in pregnancy. Whilst the majority
        are benign and resolve spontaneously, a proportion can exhibit suspicious features during
        pregnancy raising concern about an underlying malignancy. Correct classification of adnexal
        masses is particularly important during pregnancy given the potential foetal and maternal
        risks associated with surgical intervention. International Ovarian Tumour Analysis (IOTA)
        group have developed robust, ultrasound-based tools, including the ADNEX model to support the
        classification of adnexal masses. Ultrasound-based tools such the Modified Benign Simple
        Descriptors and ADNEX have been externally validated to aid in the classification of adnexal
        masses in non-pregnant women, but their use as a robust diagnostic tool in pregnancy remains
        to be demonstrated.
  
        AIMS The principal objective of this study is to prospectively investigate the ability of the
        ADNEX Model and a 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX)
        to correctly discriminate between benign and malignant adnexal masses diagnosed in pregnancy.
  
        PRIMARY OUTCOME MEASURE False discovery rate (number of benign masses / number of masses
        classified as malignant) when using the ADNEX Model to discriminate between benign and
        malignant adnexal masses at 11-14 gestational weeks in pregnancy.
  
        ELIGIBILITY All women 18 years old and above with an adnexal mass found on ultrasound scan
        during pregnancy - irrespective of whether the mass known before pregnancy OR diagnosed for
        the first time on ultrasound scan during pregnancy.
  
        DURATION This study will be conducted over a minimum period of three years.
  
        KEYWORDS IOTA, ovarian mass, benign, malignant, ultrasound, pregnancy, post-partum
  observational model: Cohort
  time perspective: Prospective
  measure: - Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: - Estimation of the false discovery rate when the ADNEX Model is applied at 11-14 weeks.
  measure: - Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: - Estimation of the false discovery rate when the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) is applied at 11-14 weeks.
  measure: - Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: - Estimation of the false discovery rate when the ADNEX Model and the 2-step strategy (i.e. Modified Benign Simple Descriptors followed by ADNEX) are applied at any time point during pregnancy;
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: C-index
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Sensitivity, Specificity)
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Calibration)
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at 11-14 weeks gestation.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Clinical utility) Net benefit.
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (C-index)
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Sensitivity, Specificity)
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Calibration)
  measure: Estimation of the ability of the ADNEX model and of the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Clinical utility) Net benefit.
  measure: - Estimation of the ability of the ADNEX model and the 2-step strategy to discriminate between benign and malignant adnexal masses when detected at any time po
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: - Estimation of the ability of the ADNEX model and the 2-step strategy (sensitivity, specificity, C-index, calibration intercept, calibration slope, clinical utility) to discriminate between benign and malignant adnexal masses when detected at any time point in pregnancy;
  measure: Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment;
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: Evaluation of change in morphology of ovarian masses throughout pregnancy based on subjective assessment;
  measure: Evaluation of change throughout pregnancy and postpartum in papillations based on subjective assessment.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: Number, size (mm), colour score (1-4), and morphology.
  measure: Change in the ultrasound appearance of endometriomas during gestation;
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: Change in the ultrasound appearance of endometriomas during gestation;
  measure: - Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: - Occurrence of complications such as rupture, torsion, or malignancy during pregnancy in patients with conservatively treated masses (cumulative incidence illustrated by 'reverse' Kaplan-Meier curves).
  measure: - Comparison of the performance of ADNEX with CA125 and that of ADNEX without CA125.
  time frame: outcome based on histology (surgery during pregnancy or within 120 days after postpartum ultrasound scan) or follow-up at postpartum scan (maximum one year after recruitment)
  description: (Specificity, Sensitivity, C-index, Calibration, Clinical Utility)
  arm group label: First arm (primary objective):
  description: First arm (primary objective): Adnexal mass scanned at 11-14 weeks. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. In addition, the patient will be asked to enter into the third arm of the study (see below) knowing that she can opt out from that arm at any point. If she consents to participate in the third arm, she will participate in a series of longitudinal examinations as described for the third arm.
  All patients with a mass detected before 11 weeks will also be scanned at 11-14 weeks and can enter all three arms of the study. In this scenario, if more than one scan is performed during pregnancy before 11 weeks, only the first of several scans before 11 weeks will be included for the second and third arms of the study.
  arm group label: Second arm (secondary objective):
  description: Second arm (secondary objective): Adnexal mass is seen for the first time during that pregnancy at any gestation. If the decision is to manage the adnexal mass conservatively, the patient is to be re-scanned once more: 0 - 90 days postpartum. For patients with a mass detected before 11 weeks, see also above (they will be re-scanned at both 11-14 weeks and at 0-90 days postpartum).
  In addition, the patient will be asked to enter into the third arm of the study knowing that she can opt out from that arm at any point. If she consents to this, she will participate in a series of longitudinal examinations as described for the third arm.
  arm group label: Third arm (secondary objective):
  description: Third arm (secondary objective): Patients from the first and second arms who agree to enrol into the third arm i.e. longitudinal examination of an adnexal mass during pregnancy. For the purposes of the longitudinal evaluation, the time points for the ultrasound examination are:
  initial presenting scan if <11 weeks;
  11-14 weeks;
  16 week scan - endometriomas ONLY;
  second trimester routine scan (18-22 weeks);
  30-34 weeks;
  any additional scans during pregnancy which resulted in either conservative management with extra scans or surgical intervention (with reason for the extra scan or for surgery documented);
  0-90 days postpartum.
  intervention type: Diagnostic Test
  intervention name: Ultrasound
  description: A standardised transvaginal (supplemented with transabdominal if transvaginal is not sufficient) examination is performed. When a colour Doppler ultrasound examination is performed, the pulse repetition frequency should be 0.3-0.6 KHz. The colour Doppler gain should be increased until colour Doppler artefacts appear and then lowered until just below the reappearance of colour Doppler artefacts. Ultrasound frequency and "priority" (grey scale or colour/Power Doppler) must also be optimised when using colour/power Doppler. Doppler ultrasound should be used with all masses included, irrespective of gestational age.
  arm group label: First arm (primary objective):
  arm group label: Second arm (secondary objective):
  arm group label: Third arm (secondary objective):
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 50 Years
  last name: Dirk Timmerman, Professor
  phone: +3216344201
  email: dirk.timmerman@uzleuven.be
  last name: Wouter Froyman, Professor
  phone: +3216344201
  email: wouter.froyman@uzleuven.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  citation: Goh WA, Rincon M, Bohrer J, Tolosa JE, Sohaey R, Riano R, Davis J, Zalud I. Persistent ovarian masses and pregnancy outcomes. J Matern Fetal Neonatal Med. 2013 Jul;26(11):1090-3. doi: 10.3109/14767058.2013.768980. Epub 2013 Feb 21.
  PMID: 23356452
  citation: Sherard GB 3rd, Hodson CA, Williams HJ, Semer DA, Hadi HA, Tait DL. Adnexal masses and pregnancy: a 12-year experience. Am J Obstet Gynecol. 2003 Aug;189(2):358-62; discussion 362-3. doi: 10.1067/s0002-9378(03)00731-2.
  PMID: 14520194
  citation: Korenaga TK, Tewari KS. Gynecologic cancer in pregnancy. Gynecol Oncol. 2020 Jun;157(3):799-809. doi: 10.1016/j.ygyno.2020.03.015. Epub 2020 Apr 5.
  PMID: 32268951
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  PMID: 29395867
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  mesh term: Ovarian Neoplasms
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