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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 February 2024
• Main ID: NCT02608346
• Date of registration: 16/11/2015
• Prospective Registration: No
• Primary sponsor: Institut Curie
• Public title: Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
• Scientific title: Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
• Date of first enrolment: November 2014
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02608346
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Jean-Yves PIERGA, DR
• Affiliation: Institut Curie

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patient with no evidence of any invasive tumor mass at inclusion (clinical and, if
any, radiological exams)

2. Carriers of known germline BRCA1 deleterious mutation (a personal history of cancer is
NOT mandatory).

3. Age = 30 years for patient with personal previous history of cancer

4. Age = 40 years for patient without personal previous history of cancer

5. Patient who a follow-up visit is scheduled in the including center at least once a
year

6. Patient having health care insurance

7. Signed informed consent by patient

Exclusion Criteria:

1. Patient presenting with invasive tumor masses (e.g. stage IV cancer or localized
cancer not yet surgically removed)

2. Carriers of germline BRCA1 variant of unknown significance

3. Carriers of germline BRCA2 deleterious mutation or variant

4. Individuals with a low risk of BRCA1-related tumor growth, i.e. women who underwent
prophylactic bilateral mastectomy AND adnexectomy.

5. Any medical or other condition that in the Investigator's opinion rendered the patient
unsuitable for this study

6. Patient deprived from ability to decide on her own.

7. Patient unable to have a regular follow up for geographical, social or psychological
reasons.



Age minimum: 30 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Women With BRCA1 Germline Deleterious Mutation

Intervention(s)

Procedure: Blood sampling

Primary Outcome(s)

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 [Time Frame: Up to 42 months]

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 [Time Frame: Up to 42 months]

Secondary Outcome(s)

Positive predictive value for mutated TP53 ctDNA [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 [Time Frame: Up to 42 months]

Positive predictive value for circulating tumor cells [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 [Time Frame: Up to 42 months]

Negative predictive value for circulating tumor cells [Time Frame: Up to 42 months]

Negative predictive value for mutated TP53 ctDNA [Time Frame: Up to 42 months]

Secondary ID(s)

IC 2014-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors