NCT03954171

Brief Summary

Prospective, monocentric study aiming to identify factors involved in platinum based-chemotherapy resistance in patients with epithelial ovarian cancer (all stages). Patients will receive treatment (platinum based-chemotherapy) according to the standard practices. A prospective database and an associated biological collection will be performed during 5 years:

  • For each patient: clinical, biological, epidemiological and therapeutic treatment data will be collected during the standard therapeutic care.
  • Biological samples (blood samples, tumor biopsy specimens and ascites samples) will be collected for all patients. These samples will be collected at the same time as those taken in standard practice (no additional biopsy will be performed for the study). Study participation of each patient will be 5 years.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
83mo left

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress48%
Mar 2020Mar 2033

First Submitted

Initial submission to the registry

May 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

March 6, 2020

Completed
13 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2033

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2033

Last Updated

November 18, 2025

Status Verified

November 1, 2025

Enrollment Period

13 years

First QC Date

May 15, 2019

Last Update Submit

November 14, 2025

Conditions

Epithelial Ovarian Cancer

Keywords

Epithelial Ovarian CancerPlatinum based-chemotherapy

Outcome Measures

Primary Outcomes (1)

  • The rate of patients alive without progression

    5 years for each patient

Secondary Outcomes (1)

  • The time to onset of platinum based-chemotherapy resistance

    5 years for each patient

Study Arms (1)

Patients treated with platinum based-chemotherapy

OTHER
Other: Patients treated with platinum based-chemotherapy

Interventions

Patients treated with platinum based-chemotherapyOTHER

Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice): * before treatment initiation (blood sample), * during hospitalisation for surgery (blood sample), * during follow-up consultations (blood sample). If tumor biopsy and/or ascites sampling are performed during the standard care, a sample will be collected for the study.

Patients treated with platinum based-chemotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • Epithelial ovarian cancer at initial diagnosis (all stages)
  • Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
  • Indication of platinum based-chemotherapy
  • Patient affiliated to the french social security system

You may not qualify if:

  • Non-epithelial ovarian tumor, borderline ovarian tumor
  • Patient with recurrent disease
  • Exploratory surgery not performed at the "Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT-O)"
  • Pregnant or breastfeeding women
  • Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures
  • Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Interventions

Platinum Compounds

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsOvarian NeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Central Study Contacts

Gwenaël FERRON

CONTACT

05 31 15 53 55Ferron.Gwenael@iuct-oncopole.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 17, 2019

Study Start

March 6, 2020

Primary Completion (Estimated)

March 1, 2033

Study Completion (Estimated)

March 1, 2033

Last Updated

November 18, 2025

Record last verified: 2025-11

Locations

FR(1)