<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/NCT01698632</url>
  </required_header>
  <id_info>
    <org_study_id>IOTA5 S51375/B32220095331</org_study_id>
    <secondary_id>USF IRB Pro00009001</secondary_id>
    <nct_id>NCT01698632</nct_id>
  </id_info>
  <brief_title>International Ovarian Tumour Analysis (IOTA) Phase 5</brief_title>
  <acronym>IOTA-5</acronym>
  <official_title>A Multicentre Study to Examine the Short and Long Term Outcomes of the Conservative Management of Benign-looking Adnexal Masses and the Pre-operative Characterisation of Ovarian Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn more about the appearance and behavior of&#xD;
      benign-looking adnexal masses.&#xD;
&#xD;
        -  Benign-looking means that when viewed here by ultrasound it has the appearance of&#xD;
           looking not harmful or not malignant.&#xD;
&#xD;
        -  Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the&#xD;
           uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa&#xD;
           includes, but is not limited to, the ovaries and the fallopian tubes.&#xD;
&#xD;
        -  Masses refers to a variety of structures, including but not limited to:&#xD;
&#xD;
             -  ovarian cysts that are fluid filled sacs within or attached to an ovary&#xD;
&#xD;
             -  ovarian tumors that can be solid tissue or a combination of cysts and solid tissue&#xD;
&#xD;
             -  hydrosalpinges that are fluid collections in the fallopian tube&#xD;
&#xD;
      Many women have what appear to be benign adnexal masses. Many times, removal of the masses&#xD;
      with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these&#xD;
      masses could be cancer. There is not much information available for doctors to know how and&#xD;
      when to follow these masses, or which ones will become cancer.&#xD;
&#xD;
      This study will combine information from centers all around the world regarding the behavior&#xD;
      of all types of benign adnexal masses. The aim of this study is to develop decision tools for&#xD;
      doctors to know the best way to treat these masses in order to improve the detection of&#xD;
      ovarian cancer while at the same time reduce the number of unnecessary operations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses</measure>
    <time_frame>Up to five years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign</measure>
    <time_frame>Up to five years</time_frame>
    <description>Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Investigate factors related to the need for surgery during long-term follow-up</measure>
    <time_frame>Up to five years</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Study natural history of conservatively treated benign-looking adnexal masses</measure>
    <time_frame>Up to five years</time_frame>
    <description>Also to establish descriptive curves of the longitudinal changes seen in parameters from conservatively managed benign tumors (for example, change in diameter, size of any solid component, number of papillations or color score)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">15000</enrollment>
  <condition>Adnexal Masses</condition>
  <condition>Ovarian Cysts</condition>
  <condition>Ovarian Tumors</condition>
  <arm_group>
    <arm_group_label>benign-looking adnexal masses</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Women being seen for adnexal masses.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any woman at least 18 years old with an adnexal mass.&#xD;
&#xD;
          -  Any mass with benign ultrasound morphology may be suitable for conservative&#xD;
             management.&#xD;
&#xD;
          -  Pregnant patients can be included, but their data will be analysed separately.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cysts that are deemed to be clearly physiological and less than 3 cm in maximum&#xD;
             diameter are not eligible for inclusion.&#xD;
&#xD;
          -  Any cyst with features of malignancy is excluded from the conservative management&#xD;
&#xD;
          -  The denial or withdrawal of oral informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dirk Timmerman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals, KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USF Health South Tampa Center for Advanced Healthcare</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>April 12, 2020</last_update_submitted>
  <last_update_submitted_qc>April 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Dirk Timmerman</investigator_full_name>
    <investigator_title>Prof. Dr. Dirk Timmerman</investigator_title>
  </responsible_party>
  <keyword>Adnexal masses</keyword>
  <keyword>Ovarian cysts</keyword>
  <keyword>Ovarian tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Cysts</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
  </condition_browse>
  <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 23, 2012</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT01698632/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 28, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT01698632/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT01698632
org study id: IOTA5 S51375/B32220095331
secondary id: USF IRB Pro00009001
nct id: NCT01698632
lead sponsor: 
has dmc: No
The purpose of this study is to learn more about the appearance and behavior of
      benign-looking adnexal masses.

        -  Benign-looking means that when viewed here by ultrasound it has the appearance of
           looking not harmful or not malignant.

        -  Adnexal refers to the 'adnexa', the space in the female pelvis on either side of the
           uterus (or where the uterus used to be if you previously had a hysterectomy). The adnexa
           includes, but is not limited to, the ovaries and the fallopian tubes.

        -  Masses refers to a variety of structures, including but not limited to:

             -  ovarian cysts that are fluid filled sacs within or attached to an ovary

             -  ovarian tumors that can be solid tissue or a combination of cysts and solid tissue

             -  hydrosalpinges that are fluid collections in the fallopian tube

      Many women have what appear to be benign adnexal masses. Many times, removal of the masses
      with surgery is not necessary. Often surgery is performed unnecessarily, for fear that these
      masses could be cancer. There is not much information available for doctors to know how and
      when to follow these masses, or which ones will become cancer.

      This study will combine information from centers all around the world regarding the behavior
      of all types of benign adnexal masses. The aim of this study is to develop decision tools for
      doctors to know the best way to treat these masses in order to improve the detection of
      ovarian cancer while at the same time reduce the number of unnecessary operations.
observational model: Cohort
time perspective: Prospective
measure: Frequency of complications such as rupture, torsion, or malignancy in patients with benign looking conservatively treated masses
time frame: Up to five years
measure: Test the published IOTA diagnostic models for predicting that a mass is malignant at first visit or benign
time frame: Up to five years
description: Also to predict complications (e.g. occurrence of malignancy and other) during long-term follow-up using the diagnostic models
measure: Investigate factors related to the need for surgery during long-term follow-up
time frame: Up to five years
measure: Study natural history of conservatively treated benign-looking adnexal masses
time frame: Up to five years
description: Also to establish descriptive curves of the longitudinal changes seen in parameters from conservatively managed benign tumors (for example, change in diameter, size of any solid component, number of papillations or color score)
arm group label: benign-looking adnexal masses
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dirk Timmerman, PhD
role: Principal Investigator
affiliation: University Hospitals, KU Leuven
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Dirk Timmerman
investigator title: Prof. Dr. Dirk Timmerman
mesh term: Ovarian Cysts
mesh term: Ovarian Neoplasms
provided document: 
provided document: 