NCT03831230

Brief Summary

Development of ex vivo models of ovarian cancer, fallopian tubes or peritoneum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 7, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

6 years

First QC Date

January 28, 2019

Last Update Submit

August 5, 2025

Conditions

Keywords

ex vivopredictive teststumor models

Outcome Measures

Primary Outcomes (1)

  • Rates of exploitable ex vivo tumor, blood and urine samples for performing predictive tests

    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

Interventions

collection of blood, urine, tumor and ascite samples during ovarian surgery

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • Pregnant woman
  • Persons deprived of liberty or guardianship (including curatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre François BACLESSE

Caen, France

Location

Related Publications (1)

  • Thorel L, Divoux J, Lequesne J, Babin G, Morice PM, Florent R, Desmartin G, Lecouflet L, Marde Alagama C, Leconte A, Clarisse B, Briand M, Rouzier R, Gaichies L, Martin-Francoise S, Le Brun JF, Denoyelle C, Vigneron N, Jeanne C, Blanc-Fournier C, Leman R, Vaur D, Figeac M, Meryet-Figuiere M, Joly F, Weiswald LB, Poulain L, Dolivet E. The OVAREX study: Establishment of ex vivo ovarian cancer models to validate innovative therapies and to identify predictive biomarkers. BMC Cancer. 2024 Jun 7;24(1):701. doi: 10.1186/s12885-024-12429-w.

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

UrinationTumor Burden

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaBody Weights and MeasuresAnthropometryInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 5, 2019

Study Start

March 7, 2019

Primary Completion

February 27, 2025

Study Completion

February 27, 2025

Last Updated

August 8, 2025

Record last verified: 2025-08

Locations