<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/NCT03302884</url>
  </required_header>
  <id_info>
    <org_study_id>CIDOC-IPC- 2016-008</org_study_id>
    <nct_id>NCT03302884</nct_id>
  </id_info>
  <brief_title>Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma</brief_title>
  <acronym>CIDOC</acronym>
  <official_title>Circulating Tumor DNA as an Early Marker of Recurrence and Treatment Efficacy in Ovarian Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut Paoli-Calmettes</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Institut Paoli-Calmettes</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 multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease&#xD;
      recurrence after front-line treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The main objective is to explore the capacity of ctDNA to be an early marker of ovarian&#xD;
      carcinoma recurrence after front-line treatments, i.e. to show significant modifications&#xD;
      before clinical diagnosis of disease relapse.&#xD;
&#xD;
      Prospective multicentre open-label study&#xD;
&#xD;
      During visits in the frame of management of the disease, blood samples will be collected at&#xD;
      diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the&#xD;
      following 2 years, and every year during the remainin time of follow-up. Tumor samples will&#xD;
      be collected at surgery or through a biopsy.&#xD;
&#xD;
      Patients will then have a standard care follow-up for a period of 5 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 10, 2018</start_date>
  <completion_date type="Anticipated">October 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse.</measure>
    <time_frame>at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years</time_frame>
    <description>Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Ovarian Carcinoma</condition>
  <arm_group>
    <arm_group_label>Biological sampling in ovarian carcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Blood and tumor samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>biological sampling</intervention_name>
    <description>Tumor and blood samples</description>
    <arm_group_label>Biological sampling in ovarian carcinoma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with suspicion of ovarian or tubar epithelial cancer, or peritoneal primitive&#xD;
             carcino-ma, without previous treatment for ovarian malignancy.&#xD;
&#xD;
          2. Indication of preoperative and/or adjuvant chemotherapy.&#xD;
&#xD;
          3. Age ≥ 18 years old.&#xD;
&#xD;
          4. Patient affiliated to the ''National security'' regimen or beneficiary of this regimen&#xD;
&#xD;
          5. Signed written informed consent prior to any screening procedures being performed&#xD;
&#xD;
        Non inclusion Criteria:&#xD;
&#xD;
          1. Contraindication to surgical assessment.&#xD;
&#xD;
          2. Pathological diagnosis of mucinous carcinoma.&#xD;
&#xD;
          3. History of concurrent malignancy or malignancy within 5 years before study enrollment,&#xD;
             (with the exceptions of adequately treated non melanomatous skin cancer or curatively&#xD;
             re-sected noninvasive cervical cancer).&#xD;
&#xD;
          4. Assessment by the investigator as being unable or unwilling to comply with the&#xD;
             require-ments of the protocol.&#xD;
&#xD;
          5. Patient in urgency situation, adult under legal protection, or unable to give his&#xD;
             consent.&#xD;
&#xD;
        Exclusion Criteria after histological exam:&#xD;
&#xD;
        Any diagnostic that is not ovarian or tubar epithelial cancer, or peritoneal primitive&#xD;
        carcinoma.&#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>Renaud SABATIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut Paoli-Calmettes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>DOMINIQUE GENRE, MD</last_name>
    <phone>33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Margot BERLINE, MSc, MBA</last_name>
    <phone>33 4 91 22 37 78</phone>
    <email>drci.up@ipc.unicancer.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Jean Perrin</name>
      <address>
        <city>Clermont Ferrand</city>
        <zip>63011</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe POMEL, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Centre Oscar Lambret</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fabrice NARDUCCI, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Institut Du Cancer de Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34298</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre-Emmanuel COLOMBO, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.institutpaolicalmettes.fr</url>
    <description>Description official web site of the sponsor</description>
  </link>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 25, 2019</last_update_submitted>
  <last_update_submitted_qc>September 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Recurrence</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/NCT03302884
org study id: CIDOC-IPC- 2016-008
nct id: NCT03302884
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective multicentre assay to assess ctDNA value for ovarian cancer monitoring and disease
      recurrence after front-line treatment.
The main objective is to explore the capacity of ctDNA to be an early marker of ovarian
      carcinoma recurrence after front-line treatments, i.e. to show significant modifications
      before clinical diagnosis of disease relapse.

      Prospective multicentre open-label study

      During visits in the frame of management of the disease, blood samples will be collected at
      diagnosis, after each cycle of eventual neoadjuvant chemotherapy, every 6 months during the
      following 2 years, and every year during the remainin time of follow-up. Tumor samples will
      be collected at surgery or through a biopsy.

      Patients will then have a standard care follow-up for a period of 5 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Prognostic value of ctDNA increase for predicting a subsequent clinical, radiological (RECIST v1.1) or biological (CA-125 according to GCIG criteria) diagnosis of disease relapse.
time frame: at diagnosis, after each cycle of eventual neo-adjuvant chemotherapy, before surgery, then every six months during the next two years, and every year in the following three years
description: Re-appearance of mutations non detectable after treatment or increase of ctDNA comparing to the nadir
arm group label: Biological sampling in ovarian carcinoma
arm group type: Experimental
description: Blood and tumor samples
intervention type: Other
intervention name: biological sampling
description: Tumor and blood samples
arm group label: Biological sampling in ovarian carcinoma
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Renaud SABATIER, MD
role: Principal Investigator
affiliation: Institut Paoli-Calmettes
last name: DOMINIQUE GENRE, MD
phone: 33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
last name: Margot BERLINE, MSc, MBA
phone: 33 4 91 22 37 78
email: drci.up@ipc.unicancer.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: France
url: http://www.institutpaolicalmettes.fr
description: Description official web site of the sponsor
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Recurrence