Platino-resistance in Ovarian Cancer

Epithelial Ovarian Cancer Clinical Trial

— PlatinOv  

Official title:

Platino-resistance in Ovarian Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03954171
• Other study ID #: 19 GENF 01
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2020
• Est. completion date: March 2030

Study information

• Verified date: August 2023
• Source: Institut Claudius Regaud
• Contact: Gwenaël FERRON
• Phone: 05 31 15 53 55
• Email: Ferron.Gwenael[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of patients alive without progression		5 years for each patient
Secondary	The time to onset of platinum based-chemotherapy resistance		5 years for each patient