Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01) (NCT02608346) | Clinical Trial Compass
CompletedNot Applicable
Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
France200 participantsStarted 2014-11
Plain-language 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).
Who can participate
Age range30 Years
SexFEMALE
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Inclusion criteria
✓. Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if any, radiological exams)
✓. Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is NOT mandatory).
✓. Age ≥ 30 years for patient with personal previous history of cancer
✓. Age ≥ 40 years for patient without personal previous history of cancer
✓. Patient who a follow-up visit is scheduled in the including center at least once a year
✓. Patient having health care insurance
✓. Signed informed consent by patient
Exclusion criteria
✕. Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized cancer not yet surgically removed)
✕. Carriers of germline BRCA1 variant of unknown significance
✕. Carriers of germline BRCA2 deleterious mutation or variant
✕. Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent prophylactic bilateral mastectomy AND adnexectomy.
✕. Any medical or other condition that in the Investigator's opinion rendered the patient unsuitable for this study
✕
What they're measuring
1
Sensitivity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation
Timeframe: Up to 42 months
2
Specificity of plasma TP53 mutation detection as a test to detect any tumor growth (relapse and/or new tumor) during the follow-up of women known to carry BRCA1 germline mutation