<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/NCT03776630</url>
  </required_header>
  <id_info>
    <org_study_id>K160922J</org_study_id>
    <secondary_id>2018-A00018-47</secondary_id>
    <nct_id>NCT03776630</nct_id>
  </id_info>
  <brief_title>Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors</brief_title>
  <acronym>GYNO-MIR</acronym>
  <official_title>Exploring the Potential of Novel Biomarkers Based on Plasma microRNAs for a Better Management of Pelvic Gynecologic Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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>
      This trial is a non-randomized, open label and multicenter study.&#xD;
&#xD;
      It aims to :&#xD;
&#xD;
      for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic&#xD;
      marker to assess the risk of lymph node metastases for ovarian cancer : to validate the&#xD;
      previous finding on the prognostic value of the pre-/post-treatment variation of miR200b&#xD;
      plasma concentrations with regards to PFS (the investigators mean the primary treatment&#xD;
      including up-front or post-chemotherapy debulking and adjuvant chemotherapy).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or&#xD;
      suppressors. There is now ample evidence that circulating miRs can be used as biomarkers.&#xD;
      This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the&#xD;
      deadliest and most frequent gynecologic malignancies.&#xD;
&#xD;
      The main challenge for physicians managing women with early-stage EC is when to opt for&#xD;
      lymphadenectomy. Tools that are currently used are not accurate enough to identify women with&#xD;
      increased risk of nodal metastases. Ballester's team recently found a relationship between&#xD;
      the high expression of a set of 5 miRs in the primary tumor and nodal status.&#xD;
&#xD;
      OC is the leading cause of death from gynecological cancer. The prognosis depends on the&#xD;
      response of the residual tumor mass to adjuvant chemotherapy. Currently, this response&#xD;
      remains largely unpredictable and even difficult to monitor with CA125 measurements and&#xD;
      current imaging techniques. Busson's team recently showed that the variation of plasma&#xD;
      miR200b during primary treatment is predictive of progression-free survival (PFS).&#xD;
&#xD;
      The study involves 3 populations of participants :&#xD;
&#xD;
        -  Patients with EC&#xD;
&#xD;
        -  Patients with OC&#xD;
&#xD;
        -  Patients undergoing surgery for benign pelvic lesions (control population)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 23, 2019</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).</measure>
    <time_frame>2 months</time_frame>
    <description>To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>For OC: PFS or death for any cause at 24 months.</measure>
    <time_frame>24 months</time_frame>
    <description>To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.</measure>
    <time_frame>2 months</time_frame>
    <description>Histopathological characteristics of the tumor in the context of EC: grade</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)</measure>
    <time_frame>2 months</time_frame>
    <description>Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC</measure>
    <time_frame>60 months</time_frame>
    <description>PFS for both EC and OC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC</measure>
    <time_frame>60 months</time_frame>
    <description>OS (defined as the time from the start of the treatment to death) for both EC and OC</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.</measure>
    <time_frame>60 months</time_frame>
    <description>it aims to validate multiplexed homogenous miR detection based on RCA-FRET compared to conventional qRT-PCR in plasma samples. It also aims to search for novel plasma miRs potentially informative on lymph node involvement (EC) or PFS (OC) by high throughput sequencing (RNA seq).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">363</enrollment>
  <condition>Ovarian Cancer</condition>
  <condition>Endometrial Cancer</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients undergoing surgery for benign pelvic lesions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ovarian Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Endometrial Cancer</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Blood sample</intervention_name>
    <description>Two blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population.&#xD;
For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Endometrial Cancer</arm_group_label>
    <arm_group_label>Ovarian Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        For all patients (EC, OC, Control)&#xD;
&#xD;
          -  Written informed consent;&#xD;
&#xD;
          -  Age ≥ 18 years old;&#xD;
&#xD;
          -  Patient affiliated to social security.&#xD;
&#xD;
        EC patients&#xD;
&#xD;
          -  Histologically proven EC ;&#xD;
&#xD;
          -  Type 1 and 2 EC;&#xD;
&#xD;
          -  FIGO stage I or II or III EC requiring first intention surgical staging.&#xD;
&#xD;
        OC patients&#xD;
&#xD;
          -  Histologically proven OC or strong suspicion of OC on clinical arguments&#xD;
             (abdomino-pelvian mass detected by palpation or echography and/or ascitis and/or&#xD;
             elevated CA125);&#xD;
&#xD;
          -  Epithelial OC: any histological subtype;&#xD;
&#xD;
          -  FIGO stage I to IV OC.&#xD;
&#xD;
        Control patients - Any lesion which is supposed to be benign and requires surgery. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For all patients (OC, EC, Control)&#xD;
&#xD;
          -  Unable or unwilling to comply with the protocol requirements and/or unwilling to sign&#xD;
             an informed consent form.&#xD;
&#xD;
          -  Deprived of liberty or under legal protection measure;&#xD;
&#xD;
          -  Ongoing pregnancy;&#xD;
&#xD;
        Control patients:&#xD;
&#xD;
        - Previous history of cancer.&#xD;
&#xD;
        EC patients&#xD;
&#xD;
          -  FIGO stage IV at preoperative imaging techniques.&#xD;
&#xD;
          -  Previous history of cancer. OC patients&#xD;
&#xD;
          -  Non epithelial cancer.&#xD;
&#xD;
          -  Previous history of cancer - except for patients who developed breast cancer at least&#xD;
             5 years or more before ovarian cancer.&#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>Geoffroy CANLORBE, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de chirurgie et oncologie gynécologique et mammaire</name>
      <address>
        <city>Paris</city>
        <state>Ile De France</state>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>September 24, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>June 29, 2022</last_update_submitted>
  <last_update_submitted_qc>June 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ovarian cancer</keyword>
  <keyword>endometrial cancer</keyword>
  <keyword>miR</keyword>
  <keyword>diagnostic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Endometrial Neoplasms</mesh_term>
    <mesh_term>Genital Neoplasms, Female</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03776630
org study id: K160922J
secondary id: 2018-A00018-47
nct id: NCT03776630
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial is a non-randomized, open label and multicenter study.

      It aims to :

      for endometrial cancer.:validate the 5-miR index assessed in plasma samples as a diagnostic
      marker to assess the risk of lymph node metastases for ovarian cancer : to validate the
      previous finding on the prognostic value of the pre-/post-treatment variation of miR200b
      plasma concentrations with regards to PFS (the investigators mean the primary treatment
      including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
MicroRNAs (miRs) have been linked to carcinogenesis and can act as metastatic activators or
      suppressors. There is now ample evidence that circulating miRs can be used as biomarkers.
      This project is focused on ovarian (OC) and endometrial cancers (EC), respectively the
      deadliest and most frequent gynecologic malignancies.

      The main challenge for physicians managing women with early-stage EC is when to opt for
      lymphadenectomy. Tools that are currently used are not accurate enough to identify women with
      increased risk of nodal metastases. Ballester's team recently found a relationship between
      the high expression of a set of 5 miRs in the primary tumor and nodal status.

      OC is the leading cause of death from gynecological cancer. The prognosis depends on the
      response of the residual tumor mass to adjuvant chemotherapy. Currently, this response
      remains largely unpredictable and even difficult to monitor with CA125 measurements and
      current imaging techniques. Busson's team recently showed that the variation of plasma
      miR200b during primary treatment is predictive of progression-free survival (PFS).

      The study involves 3 populations of participants :

        -  Patients with EC

        -  Patients with OC

        -  Patients undergoing surgery for benign pelvic lesions (control population)
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: For EC: presence or absence of lymph-node metastases according to pathological analysis (reference technique).
time frame: 2 months
description: To validate the 5-miR index assessed in plasma samples as a diagnostic marker to assess the risk of lymph node metastases.
measure: For OC: PFS or death for any cause at 24 months.
time frame: 24 months
description: To validate the previous finding on the prognostic value of the pre-/post-treatment variation of miR200b plasma concentrations with regards to PFS (by OC treatment, we mean the primary treatment including up-front or post-chemotherapy debulking and adjuvant chemotherapy).
measure: It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC.
time frame: 2 months
description: Histopathological characteristics of the tumor in the context of EC: grade
measure: It aims to investigate the links of the 5-miR index with classical predictors of lymph node involvement in the context of EC (1)
time frame: 2 months
description: Histopathological characteristics of the tumor in the context of EC: type endometrioid vs. non endometrioid
measure: It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of PFS in EC and OC
time frame: 60 months
description: PFS for both EC and OC
measure: It aims to assess the prognostic value of pre/post-operative plasma miR variations in terms of OS in EC and OC
time frame: 60 months
description: OS (defined as the time from the start of the treatment to death) for both EC and OC
measure: Sensitivity and specificity of plasma miR detection by RCA-FRET applied directly on plasma samples or following RNA extraction.
time frame: 60 months
description: it aims to validate multiplexed homogenous miR detection based on RCA-FRET compared to conventional qRT-PCR in plasma samples. It also aims to search for novel plasma miRs potentially informative on lymph node involvement (EC) or PFS (OC) by high throughput sequencing (RNA seq).
arm group label: Control
arm group type: Other
description: Patients undergoing surgery for benign pelvic lesions
arm group label: Ovarian Cancer
arm group type: Other
arm group label: Endometrial Cancer
arm group type: Other
intervention type: Other
intervention name: Blood sample
description: Two blood samples (2 tubes of 4 ml for each blood sample) will be collected per patient during the study period for EC and OC. One blood sample will be collected for control population. The first sample will be collected prior to any treatment for EC, OC, and control population.
For EC, the second collection will be done one month post-surgery. For OC, the second collection will be done 6 to 9 months after the initial diagnosis, in most cases at the completion of adjuvant chemotherapy. For control population, there will be no second sample.
arm group label: Control
arm group label: Endometrial Cancer
arm group label: Ovarian Cancer
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geoffroy CANLORBE, Doctor
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Endometrial Neoplasms
mesh term: Genital Neoplasms, Female
sharing ipd: Undecided