Women With BRCA1 Germline Deleterious MutationNCT02608346
Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
A study testing Blood sampling in people with Women With BRCA1 Germline Deleterious Mutation, run by Institut Curie at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Women With BRCA1 Germline Deleterious Mutation
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2014to 29 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Léon Bérard
Lyon, 69273
Institut Curie
Paris, 75005
Hôpital René Huguenin - Institut Curie
Saint-Cloud, 92210
Institut Gustave ROUSSY
Villejuif, 94805
About this study
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).
- Being tested
- Blood sampling
- Keywords
- Circulating tumor DNA, BRCA1 mutation, Circulating tumor cells
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Blood sampling | Other | Not described Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Up to 42 months
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startNov 2014
- Primary completion29 Dec 2021
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women With BRCA1 Germline Deleterious MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Yves PIERGA, DR, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608346
- Sponsor's protocol ID
- IC 2014-05
- Status last verified
- Jan 2024
- First submitted
- 16 Nov 2015
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Tumor DNA and Follow-up of BRCA1 Mutation Carriers (CirCa 01)
- ClinicalTrials.gov ID
- NCT02608346
- Acronym / sponsor ID
- IC 2014-05
- Keywords
- Circulating tumor DNA, BRCA1 mutation, Circulating tumor cells
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- 29 Dec 2021 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 18 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sampling | Other | Procedure: Blood sampling |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingPatients 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 | Procedure or surgery | Blood sampling |
Primary outcome
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).
6 secondary outcomes
Positive predictive value for mutated TP53 ctDNA
Time frame: Up to 42 months
Negative predictive value for mutated TP53 ctDNA
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
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
Negative predictive value for circulating tumor cells
Time frame: Up to 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Yves PIERGA, DR principal investigator
Institut Curie
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Women With BRCA1 Germline Deleterious Mutation, run by Institut Curie at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.