An interventional study of Blood sampling in Women With BRCA1 Germline Deleterious Mutation, sponsored by Institut Curie. Completed at 4 sites in France. Open to female participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Institut Curie · Not applicable, Interventional, and Diagnostic
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).
Institut Curie is the lead sponsor of 134 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Plan to share: Yes — Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Supporting information: Sap
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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