OVAREX: 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
Sponsor
Centre Francois Baclesse (Other)
Overall Status
Recruiting
CT.gov ID
NCT03831230
Collaborator
(none)
160
1
124.8
1.3
Study Details
Study Description
Brief Summary
Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
160 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
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
Actual Study Start Date
:
Mar 7, 2019
Anticipated Primary Completion Date
:
Aug 1, 2024
Anticipated Study Completion Date
:
Aug 1, 2029
Outcome Measures
Primary Outcome Measures
- Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests [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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre François BACLESSE | Caen | France |
Sponsors and Collaborators
- Centre Francois Baclesse
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT03831230
Other Study ID Numbers:
- 2018-A02152-53
First Posted:
Feb 5, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Francois Baclesse
Additional relevant MeSH terms: