search
Back to results

Platino-resistance in Ovarian Cancer (PlatinOv)

Primary Purpose

Epithelial Ovarian Cancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients treated with platinum based-chemotherapy
Sponsored by
Institut Claudius Regaud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Epithelial Ovarian Cancer focused on measuring Epithelial Ovarian Cancer, Platinum based-chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Epithelial ovarian cancer at initial diagnosis (all stages)
  3. Curative treatment (exeresis surgery) not yet initiated excepted neo-adjuvant treatment
  4. Indication of platinum based-chemotherapy
  5. Patient affiliated to the french social security system
  6. Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure

Exclusion Criteria:

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

Sites / Locations

  • Institut Universitaire du Cancer de Toulouse - OncopoleRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients treated with platinum based-chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

The rate of patients alive without progression

Secondary Outcome Measures

The time to onset of platinum based-chemotherapy resistance

Full Information

First Posted
May 15, 2019
Last Updated
August 2, 2023
Sponsor
Institut Claudius Regaud
search

1. Study Identification

Unique Protocol Identification Number
NCT03954171
Brief Title
Platino-resistance in Ovarian Cancer
Acronym
PlatinOv
Official Title
Platino-resistance in Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2020 (Actual)
Primary Completion Date
March 2030 (Anticipated)
Study Completion Date
March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epithelial Ovarian Cancer
Keywords
Epithelial Ovarian Cancer, Platinum based-chemotherapy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients treated with platinum based-chemotherapy
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Patients treated with platinum based-chemotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The rate of patients alive without progression
Time Frame
5 years for each patient
Secondary Outcome Measure Information:
Title
The time to onset of platinum based-chemotherapy resistance
Time Frame
5 years for each patient

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Patient must provide written informed consent prior to inclusion in the study and any study-specific procedure Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gwenaël FERRON
Phone
05 31 15 53 55
Email
Ferron.Gwenael@iuct-oncopole.fr
Facility Information:
Facility Name
Institut Universitaire du Cancer de Toulouse - Oncopole
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gwenaël FERRON
Phone
05 31 15 53 55
Email
Ferron.Gwenael@iuct-oncopole.fr

12. IPD Sharing Statement

Learn more about this trial

Platino-resistance in Ovarian Cancer

We'll reach out to this number within 24 hrs