Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02608346 |
Recruitment Status :
Completed
First Posted : November 18, 2015
Last Update Posted : January 19, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Women With BRCA1 Germline Deleterious Mutation | Procedure: Blood sampling | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01) |
Actual Study Start Date : | November 2014 |
Actual Primary Completion Date : | December 29, 2021 |
Actual Study Completion Date : | December 29, 2021 |
Arm | Intervention/treatment |
---|---|
Blood sampling |
Procedure: Blood sampling
Patients will have a blood draw at each visit to the hospital,
|
- 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 ]Sensitivity = % of patients with detectable levels of mutated TP53 ctDNA among those who experience a new tumor growth (relapse and/or new tumor).
- 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 ]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).
- Positive predictive value for mutated TP53 ctDNA [ Time Frame: Up to 42 months ]Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when mutated TP53 ctDNA is detectable.
- Negative predictive value for mutated TP53 ctDNA [ Time Frame: Up to 42 months ]Negative predictive value = Probability of being without tumor growth when mutated TP53 ctDNA is not detectable.
- 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 ]Sensitivity = % of patients with detectable levels of circulating tumor cells among those who experience a new tumor growth (relapse and/or new tumor).
- 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 ]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).
- Positive predictive value for circulating tumor cells [ Time Frame: Up to 42 months ]Positive predictive value = Probability of having a tumor growth (relapse and/or new tumor) when circulating tumor cells is detectable.
- Negative predictive value for circulating tumor cells [ Time Frame: Up to 42 months ]Negative predictive value = Probability of being without tumor growth when circulating tumor cells is not detectable.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 30 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
- Patient deprived from ability to decide on her own.
- Patient unable to have a regular follow up for geographical, social or psychological reasons.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608346
France | |
Centre Léon Bérard | |
Lyon, France, 69273 | |
Institut Curie | |
Paris, France, 75005 | |
Hôpital René Huguenin - Institut Curie | |
Saint-cloud, France, 92210 | |
Institut Gustave ROUSSY | |
Villejuif, France, 94805 |
Principal Investigator: | Jean-Yves PIERGA, DR | Institut Curie |
Responsible Party: | Institut Curie |
ClinicalTrials.gov Identifier: | NCT02608346 |
Other Study ID Numbers: |
IC 2014-05 |
First Posted: | November 18, 2015 Key Record Dates |
Last Update Posted: | January 19, 2022 |
Last Verified: | January 2022 |
Circulating tumor DNA BRCA1 mutation Circulating tumor cells |