NCT02608346

Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

BRCA1 carriers who are at high risk of developing either a relapse and/or a new cancer growth will be included. These patients will be followed up during 30 months (2,5 years) with mutated TP53 mutation detection or during 42 months (3,5 years) with mutated TP53 mutation detection and circulating tumor cells detection (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

Conditions

• Women With BRCA1 Germline Deleterious Mutation

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Patients will have a blood draw at each visit to the hospital, * with a maximum of 1 blood draw every 3 months, in absence of any abnormal clinical/radiological exam * with a maximum of 1 blood draw every week, in case of abnormal clinical/radiological exam that requires further investigation

Timeline

• Start date: 2014-11-01
• Primary completion: 2021-12-29
• Completion: 2021-12-29
• First posted: 2015-11-18
• Last updated: 2024-01-31

Locations

4 sites across 1 country: France