<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/NCT03808792</url>
  </required_header>
  <id_info>
    <org_study_id>č.j. 29/18</org_study_id>
    <nct_id>NCT03808792</nct_id>
  </id_info>
  <brief_title>Imaging Study in Advanced Ovarian Cancer</brief_title>
  <acronym>ISAAC</acronym>
  <official_title>A Comparison Between Ultrasound, CT (CT) and Whole-body Diffusion-weighted MRI (WB-DWI/MRI) in the Assessment of Operability in Patients With Ovarian Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Charles University, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of the study is the assessment of tumour sites critical for the achievement of&#xD;
      optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and&#xD;
      WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with&#xD;
      non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are&#xD;
      equivalent to a portion of cases identified during surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal&#xD;
      cancer using subjective assessment by experienced sonographer (principal investigator) will&#xD;
      be enrolled in the study and send to surgical planning. During surgical planning, the CT and&#xD;
      MRI will be scheduled and the patient ́s consent will be requested if inclusion criteria are&#xD;
      fulfilled. Please note, tumors with atypical morphology and/or tumor spread suspicious for&#xD;
      secondary ovarian cancer will be first subjected to a tru-cut biopsy and will be included if&#xD;
      histopathology confirms adnexal or peritoneal cancer.&#xD;
&#xD;
      Ultrasound will be always performed by the principal investigator in each center. Principal&#xD;
      investigator is an ultrasound expert with level II or III EFSUMB accreditation&#xD;
      (http://www.efsumb.org/). Operators performing ultrasound scan and radiologists performing CT&#xD;
      or MRI will be well instructed and educated about standardized approach and criteria of&#xD;
      inoperability. Sonographers and radiologists will be blinded to the results of other imaging&#xD;
      modalities. If a patient already had CT or WB-DWI/MRI done by the referring hospital, the&#xD;
      study radiologists will decide about the quality of imaging and necessity to repeat CT or&#xD;
      WB-DWI/MRI.&#xD;
&#xD;
      The decision to treat by PDS (primary debulking surgery), or by NACT (neoadjuvant&#xD;
      chemotherapy) with IDS (interval debulking surgery) will be based on departmental guidelines&#xD;
      taking into account medical comorbidities and disease-related factors. If a patient is&#xD;
      indicated for NACT a tru-cut biopsy or/and a diagnostic laparoscopy are performed. The&#xD;
      clinicians will document why the primary debulking surgery was not considered. The surgery&#xD;
      (laparoscopy, primary or interval debulking surgery) should always be performed within four&#xD;
      weeks after the index test. Patients without surgical exploration will be excluded.&#xD;
&#xD;
      Surgeons performing laparoscopy will describe site to site involvement and in case of&#xD;
      inoperability will take a biopsy and document reasons for abandoning laparotomy. In operable&#xD;
      cases surgeons performing laparotomy will describe site to site involvement and where&#xD;
      applicable reasons for not achieving optimal cytoreduction defined as no residual tumor left&#xD;
      in situ at the end of surgery (R0).&#xD;
&#xD;
      If the patient has only ultrasound and CT (and not WB-DWI/MRI) she can still be included in&#xD;
      the study. Similarly if the patient undergoes interval debulking surgery she can be included&#xD;
      in the study if the index tests will be performed less than 4 week before IDS.&#xD;
&#xD;
      Clinical data and four evaluation forms will be filled in (Ultrasound, CT, MRI, Surgery)&#xD;
      immediately after the procedure using electronic database. The evaluation form from&#xD;
      histopathology will be filled when available by principal investigator. The database cannot&#xD;
      be saved unless all the information required are filled in and it will not be available to&#xD;
      any other investigator. Data will be submitted for statistical analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.</measure>
    <time_frame>24 months</time_frame>
    <description>Optimal debulking is defined as residual disease &lt;1cm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form.</measure>
    <time_frame>24 months</time_frame>
    <description>Detection of involvement of individual sites relevant for clinical management:&#xD;
Rectosigmoid&#xD;
Colon (except ileocecum)&#xD;
Ileocaecum&#xD;
Lesser omentum&#xD;
Small intestine&#xD;
Liver&#xD;
Diaphragm&#xD;
Pleura&#xD;
Detection of 24 individual sites described in the evaluation form (17 peritoneal sites and 7 lymph nodes sites).&#xD;
The aim is to clarify the diagnostic performance of the different imaging methods in the assessment of tumor extent in form of peritoneal carcinomatosis and metastatic lymph nodes. The investigators want to establish the overall accuracy of each imaging modality in all the metastatic sites. The major interest lies in the sites that determine the extent of surgery and optimal cytoreduction, in particular bowel resection, lesser omentum, superficial liver metastases, diaphragm or pleura.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prediction model of achievement of optimal cytoreduction.</measure>
    <time_frame>24 months</time_frame>
    <description>Prediction of optimal cytoreduction based on preoperative imaging. Optimal cytoreduction is defined as no residual tumor left at the end of surgery (R0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - FIGO stage</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
FIGO stage - it will be analised if the accuracy of the imaging methods change between early stages (I-II) and late stages (III-IV) of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Histological type</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Histological type - it will be analised if the accuracy of the imaging methods change between serous type and other histological types</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Origin</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods: Origin - it will be analised if the accuracy of the imaging methods change between ovarian origin and tubal origin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Intraperitoneal fluid</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Intraperitoenal fluid - it will be analised if the accuracy of the imaging methods change between &lt; or = 400 mL and &gt; 400 mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Age</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Age - it will be analised if the accuracy of the imaging methods change between women with &lt; or = 65 and &gt; 65 years old</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - CA 125</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
CA 125 - it will be analised if the accuracy of the imaging methods change between &lt; or = 300 U/mL and &gt; 300 U/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Postmenopausal status</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Postmenopausal status - it will be analised if the accuracy of the imaging methods change between premnopausal and postmenopausal status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Body mass index</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Body mass índex - it will be analised if the accuracy of the imaging methods change between &lt; or = 25 kg/m2 and &gt; 25 kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Markers influencing accuracy - Image quality</measure>
    <time_frame>24 months</time_frame>
    <description>Assessment of markers influencing diagnostic accuracy of individual methods:&#xD;
Image quality - it will be analised if the accuracy of the imaging methods change between good, moderate and poor image quality</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Patient Method Friendly Questionnaire</measure>
    <time_frame>24 months</time_frame>
    <description>Evaluation of patients' experience of the imaging modalities using Patient Method Friendly Questionnaire.&#xD;
The aim of the questionnaire is to evaluate the overall experience through the different imaging methods and to evaluate relevant factors that may had a negative impact on the examination. The answers should be in a 4-point scale (1-very disappointing; 2-disappointing; 3- satisfied; 4-very satisfied) except the level of pain that should be in a 10-scale of pain (1 - no pain; 10 - maximum pain)</description>
  </other_outcome>
  <other_outcome>
    <measure>Excluded patients</measure>
    <time_frame>24 months</time_frame>
    <description>Monitorization of excluded patients using an evaluation form filled by the principal investigator or study coordinator in each center. It has to be chosen one of the next options:&#xD;
Age &lt;18 or &gt; 80 years old&#xD;
Poor performance status ECOG &gt;3&#xD;
Histologic report of biopsy of a non-gynecologic cancer&#xD;
Contraindications to upfront LPS or LPT (only tru-cut biopsy +/- NACT)&#xD;
Contraindications to CT&#xD;
Consent not given by the patient (denial or withdrawal of oral informed consent)&#xD;
Absence of insurance&#xD;
Time between ultrasound and surgery more than 4 weeks&#xD;
Current pregnancy&#xD;
Death&#xD;
Others, please specify:</description>
  </other_outcome>
  <other_outcome>
    <measure>Record of choice of treatment</measure>
    <time_frame>24 months</time_frame>
    <description>Record of multidisciplinary team choice of primary surgery or neoadjuvant chemotherapy to clarify personal and external factors in decision making</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Ovarian cancer patients</arm_group_label>
    <description>Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound, CT and WB-DWI/MRI</intervention_name>
    <description>Preoperative assessment with Ultrasound, CT and WB-DWI/MRI</description>
    <arm_group_label>Ovarian cancer patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or&#xD;
        peritoneal cancer&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer&#xD;
             using subjective assessment by experienced sonographer.&#xD;
&#xD;
          2. Surgery (PDS or IDS) within 4 weeks from the index test.&#xD;
&#xD;
          3. 18 &gt; Age &lt; 80.&#xD;
&#xD;
          4. ECOG (Eastern Cooperative Oncology Group) grade &lt; 3.&#xD;
&#xD;
          5. Patients after NACT can be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound.&#xD;
&#xD;
          2. Patients with supradiaphragmatic metastases&#xD;
&#xD;
          3. Contraindications to CT&#xD;
&#xD;
          4. Medical contraindications to surgery&#xD;
&#xD;
          5. Refusal or withdrawal of written informed consent&#xD;
&#xD;
          6. Time lapse between ultrasound and surgery more than 4 weeks&#xD;
&#xD;
          7. Current pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female patients</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniela Fischerová, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrícia Pinto, MD</last_name>
    <phone>+351912414130</phone>
    <email>aplpinto@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Daniela Fischerová, MD, PhD</last_name>
    <phone>+420603285097</phone>
    <email>daniela.fischerova@seznam.cz</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Gynecologic Oncology Center in Prague</name>
      <address>
        <city>Prague</city>
        <zip>15000</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <contact>
      <last_name>Daniela Fischerová, MD, PhD</last_name>
      <phone>+420603285097</phone>
      <email>daniela.fischerova@seznam.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Ana Patrícia Pinto</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Ovarian cancer</keyword>
  <keyword>Ultrasound</keyword>
  <keyword>CT</keyword>
  <keyword>WB-DW/MRI</keyword>
  <keyword>Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03808792
org study id: č.j. 29/18
nct id: NCT03808792
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of the study is the assessment of tumour sites critical for the achievement of
      optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and
      WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with
      non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are
      equivalent to a portion of cases identified during surgery.
Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal
      cancer using subjective assessment by experienced sonographer (principal investigator) will
      be enrolled in the study and send to surgical planning. During surgical planning, the CT and
      MRI will be scheduled and the patient ́s consent will be requested if inclusion criteria are
      fulfilled. Please note, tumors with atypical morphology and/or tumor spread suspicious for
      secondary ovarian cancer will be first subjected to a tru-cut biopsy and will be included if
      histopathology confirms adnexal or peritoneal cancer.

      Ultrasound will be always performed by the principal investigator in each center. Principal
      investigator is an ultrasound expert with level II or III EFSUMB accreditation
      (http://www.efsumb.org/). Operators performing ultrasound scan and radiologists performing CT
      or MRI will be well instructed and educated about standardized approach and criteria of
      inoperability. Sonographers and radiologists will be blinded to the results of other imaging
      modalities. If a patient already had CT or WB-DWI/MRI done by the referring hospital, the
      study radiologists will decide about the quality of imaging and necessity to repeat CT or
      WB-DWI/MRI.

      The decision to treat by PDS (primary debulking surgery), or by NACT (neoadjuvant
      chemotherapy) with IDS (interval debulking surgery) will be based on departmental guidelines
      taking into account medical comorbidities and disease-related factors. If a patient is
      indicated for NACT a tru-cut biopsy or/and a diagnostic laparoscopy are performed. The
      clinicians will document why the primary debulking surgery was not considered. The surgery
      (laparoscopy, primary or interval debulking surgery) should always be performed within four
      weeks after the index test. Patients without surgical exploration will be excluded.

      Surgeons performing laparoscopy will describe site to site involvement and in case of
      inoperability will take a biopsy and document reasons for abandoning laparotomy. In operable
      cases surgeons performing laparotomy will describe site to site involvement and where
      applicable reasons for not achieving optimal cytoreduction defined as no residual tumor left
      in situ at the end of surgery (R0).

      If the patient has only ultrasound and CT (and not WB-DWI/MRI) she can still be included in
      the study. Similarly if the patient undergoes interval debulking surgery she can be included
      in the study if the index tests will be performed less than 4 week before IDS.

      Clinical data and four evaluation forms will be filled in (Ultrasound, CT, MRI, Surgery)
      immediately after the procedure using electronic database. The evaluation form from
      histopathology will be filled when available by principal investigator. The database cannot
      be saved unless all the information required are filled in and it will not be available to
      any other investigator. Data will be submitted for statistical analysis.
observational model: Cohort
time perspective: Prospective
measure: Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.
time frame: 24 months
description: Optimal debulking is defined as residual disease <1cm
measure: Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form.
time frame: 24 months
description: Detection of involvement of individual sites relevant for clinical management:
Rectosigmoid
Colon (except ileocecum)
Ileocaecum
Lesser omentum
Small intestine
Liver
Diaphragm
Pleura
Detection of 24 individual sites described in the evaluation form (17 peritoneal sites and 7 lymph nodes sites).
The aim is to clarify the diagnostic performance of the different imaging methods in the assessment of tumor extent in form of peritoneal carcinomatosis and metastatic lymph nodes. The investigators want to establish the overall accuracy of each imaging modality in all the metastatic sites. The major interest lies in the sites that determine the extent of surgery and optimal cytoreduction, in particular bowel resection, lesser omentum, superficial liver metastases, diaphragm or pleura.
measure: Prediction model of achievement of optimal cytoreduction.
time frame: 24 months
description: Prediction of optimal cytoreduction based on preoperative imaging. Optimal cytoreduction is defined as no residual tumor left at the end of surgery (R0).
measure: Markers influencing accuracy - FIGO stage
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
FIGO stage - it will be analised if the accuracy of the imaging methods change between early stages (I-II) and late stages (III-IV) of the disease
measure: Markers influencing accuracy - Histological type
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Histological type - it will be analised if the accuracy of the imaging methods change between serous type and other histological types
measure: Markers influencing accuracy - Origin
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods: Origin - it will be analised if the accuracy of the imaging methods change between ovarian origin and tubal origin
measure: Markers influencing accuracy - Intraperitoneal fluid
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Intraperitoenal fluid - it will be analised if the accuracy of the imaging methods change between < or = 400 mL and > 400 mL
measure: Markers influencing accuracy - Age
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Age - it will be analised if the accuracy of the imaging methods change between women with < or = 65 and > 65 years old
measure: Markers influencing accuracy - CA 125
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
CA 125 - it will be analised if the accuracy of the imaging methods change between < or = 300 U/mL and > 300 U/mL
measure: Markers influencing accuracy - Postmenopausal status
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Postmenopausal status - it will be analised if the accuracy of the imaging methods change between premnopausal and postmenopausal status
measure: Markers influencing accuracy - Body mass index
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Body mass índex - it will be analised if the accuracy of the imaging methods change between < or = 25 kg/m2 and > 25 kg/m2
measure: Markers influencing accuracy - Image quality
time frame: 24 months
description: Assessment of markers influencing diagnostic accuracy of individual methods:
Image quality - it will be analised if the accuracy of the imaging methods change between good, moderate and poor image quality
measure: Patient Method Friendly Questionnaire
time frame: 24 months
description: Evaluation of patients' experience of the imaging modalities using Patient Method Friendly Questionnaire.
The aim of the questionnaire is to evaluate the overall experience through the different imaging methods and to evaluate relevant factors that may had a negative impact on the examination. The answers should be in a 4-point scale (1-very disappointing; 2-disappointing; 3- satisfied; 4-very satisfied) except the level of pain that should be in a 10-scale of pain (1 - no pain; 10 - maximum pain)
measure: Excluded patients
time frame: 24 months
description: Monitorization of excluded patients using an evaluation form filled by the principal investigator or study coordinator in each center. It has to be chosen one of the next options:
Age <18 or > 80 years old
Poor performance status ECOG >3
Histologic report of biopsy of a non-gynecologic cancer
Contraindications to upfront LPS or LPT (only tru-cut biopsy +/- NACT)
Contraindications to CT
Consent not given by the patient (denial or withdrawal of oral informed consent)
Absence of insurance
Time between ultrasound and surgery more than 4 weeks
Current pregnancy
Death
Others, please specify:
measure: Record of choice of treatment
time frame: 24 months
description: Record of multidisciplinary team choice of primary surgery or neoadjuvant chemotherapy to clarify personal and external factors in decision making
arm group label: Ovarian cancer patients
description: Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery
intervention type: Diagnostic Test
intervention name: Ultrasound, CT and WB-DWI/MRI
description: Preoperative assessment with Ultrasound, CT and WB-DWI/MRI
arm group label: Ovarian cancer patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female patients
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Daniela Fischerová, MD, PhD
role: Study Chair
affiliation: Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic
last name: Patrícia Pinto, MD
phone: +351912414130
email: aplpinto@gmail.com
last name: Daniela Fischerová, MD, PhD
phone: +420603285097
email: daniela.fischerova@seznam.cz
facility: 
contact: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Ana Patrícia Pinto
investigator title: Principal Investigator
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial