PlatinOv: Platino-resistance in Ovarian Cancer

Sponsor
Institut Claudius Regaud (Other)
Overall Status
Recruiting
CT.gov ID
NCT03954171
Collaborator
(none)
600
1
1
119.8
5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Patients treated with platinum based-chemotherapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Platino-resistance in Ovarian Cancer
Actual Study Start Date :
Mar 6, 2020
Anticipated Primary Completion Date :
Mar 1, 2030
Anticipated Study Completion Date :
Mar 1, 2030

Arms and Interventions

Arm Intervention/Treatment
Other: Patients treated with platinum based-chemotherapy

Other: Patients treated with platinum based-chemotherapy
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.

Outcome Measures

Primary Outcome Measures

  1. The rate of patients alive without progression [5 years for each patient]

Secondary Outcome Measures

  1. The time to onset of platinum based-chemotherapy resistance [5 years for each patient]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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)"
  1. Pregnant or breastfeeding women

  2. Any psychological, familial, geographical or sociological condition potentially preventing the medical follow-up and/or study procedures

  3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Institut Universitaire du Cancer de Toulouse - Oncopole Toulouse France

Sponsors and Collaborators

  • Institut Claudius Regaud

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Institut Claudius Regaud
ClinicalTrials.gov Identifier:
NCT03954171
Other Study ID Numbers:
  • 19 GENF 01
First Posted:
May 17, 2019
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Institut Claudius Regaud
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2022