Constitution of ex Vivo Ovarian Tumor Models for the Validation of the Interest of Innovative Therapies and the Search for Tumor or Circulating Biomarkers Predictive of Treatment Response (OVAREX)

July 20, 2021 updated by: Centre Francois Baclesse
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
        • Recruiting
        • Centre François Baclesse
        • Contact:
          • Enora DOLIVET, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.

Description

Inclusion Criteria:

  • Patient over 18 years old.
  • Patient with ovarian cancer, carcinoma of the fallopian tubes, or histologically proven peritoneum. All FIGO stages are accepted for the study.
  • Patient to be managed by surgery (laparoscopy and / or laparotomy).

Exclusion Criteria:

  • Pregnant woman
  • Persons deprived of liberty or guardianship (including curatorship)
  • History of any other clinically active malignancy in the last 5 years prior to inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests
Time Frame: Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery
Number and quality of tumor, blood and urine samples that can be used to perform predictive tests of the response to treatment
Collection of blood, urine, tumor and ascite samples at the time of ovarian surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2019

Primary Completion (ANTICIPATED)

August 1, 2024

Study Completion (ANTICIPATED)

August 1, 2029

Study Registration Dates

First Submitted

January 28, 2019

First Submitted That Met QC Criteria

February 4, 2019

First Posted (ACTUAL)

February 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02152-53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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