Prognostic and Predictive Biomarkers in Ovarian Cancers

Ovarian Cancer Clinical Trial

— OvBIOMark  

Official title:

Prognostic and Predictive Biomarkers in Ovarian Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03010124
• Other study ID #: 2015-A01183-46
• Secondary ID: 2015/2290
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2016
• Est. completion date: September 2022

Study information

• Verified date: February 2020
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Alexandra LEARY, MD
• Phone: 0142114389
• Email: alexandra.leary[@]gustaveroussy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators therefore propose to conduct a biological study of prospectively collected patient tumour samples, ascites, blood and other residual samples (feces, urine, cervical smear) throughout the disease course where markers (at diagnosis and their change with treatment) will be correlated to outcome in order to investigate how genetic diversity in OC prior to treatment and adaptation following treatment contribute to chemotherapy resistance. In addition freshly collected ascitic samples (and tumour samples) will be subjected to ex vivo DNA repair functional assays and isolated in primary culture (and established as xenografts) for target validation experiments.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2022
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. New patient with a diagnosis of OC, or

2. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center presenting with progressive disease, and consenting to CT guided biopsy of relapsed disease, or

3. Previously treated patient with frozen or formalin fixed paraffin embedded primary tumour sample available that can be retrieved by the center scheduled for surgery for relapsed disease.

4. Signed informed consent

5. Age = 18

6. Patient affiliated to a social security regimen or beneficiary of the same

Exclusion Criteria:

1. Patients who do not fit the inclusion criteria and those who refuse an antitumoral treatment;

2. Coagulation abnormalities that contra-indicates the biopsy

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• Blood sample

Locations

Country	Name	City	State
France	Gustave Roussy	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival	up to 12 months	Correlation of baseline biomarkers with PFS will occur at 12 months following last patient inclusion