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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
200
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
Centre Léon Bérard
Lyon, France
Institut Curie
Paris, France
Hôpital René Huguenin - Institut Curie
Saint-Cloud, France
Institut Gustave ROUSSY
Villejuif, France
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
Sensitivity = % of patients with detectable levels of mutated TP53 ctDNA among those who experience a new tumor growth (relapse and/or new tumor).
Time frame: Up to 42 months
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
Specificity = % of patients with undetectable levels of mutated TP53 ctDNA among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).
Time frame: Up to 42 months
Positive predictive value for mutated TP53 ctDNA
Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when mutated TP53 ctDNA is detectable.
Time frame: Up to 42 months
Negative predictive value for mutated TP53 ctDNA
Negative predictive value = Probability of being without tumor growth when mutated TP53 ctDNA is not detectable.
Time frame: Up to 42 months
Sensitivity of circulating tumor cells 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
Sensitivity = % of patients with detectable levels of circulating tumor cells among those who experience a new tumor growth (relapse and/or new tumor).
Time frame: Up to 42 months
Specificity of circulating tumor cells 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
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Specificity = % of patients with undetectable levels of circulating tumor cells among those who don't experience a new tumor growth (diagnosed within 6 months after the blood draw).
Time frame: Up to 42 months
Positive predictive value for circulating tumor cells
Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when circulating tumor cells is detectable.
Time frame: Up to 42 months
Negative predictive value for circulating tumor cells
Negative predictive value = Probability of being without tumor growth when circulating tumor cells is not detectable.
Time frame: Up to 42 months