- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03831230
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)
August 5, 2025 updated by: Centre Francois Baclesse
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Caen, France
- Centre Francois Baclesse
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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
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
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 (Actual)
February 27, 2025
Study Completion (Actual)
February 27, 2025
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)
August 8, 2025
Last Update Submitted That Met QC Criteria
August 5, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Endocrine Gland Neoplasms
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Ovarian Neoplasms
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
product manufactured in and exported from the U.S.
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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