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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2021-12-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma

NCT01334008

Choroidal Melanoma, Diffuse

COMPLETED NA

Upfront Systematic Tumour BRCA Testing in Patients With High Grade Serous or Endometrioid Ovarian, Fallopian Tube or Primary Peritoneal Cancer (HGSEC): The t-BRCA Study

NCT06274541

Serous Ovarian Tumor Endometrioid Carcinoma Ovary Fallopian Tube Cancer +1 more

ACTIVE_NOT_RECRUITING

PREDICTION OF GERMLINE BRCA 1/2 GENES FROM HEALTHY OVARIES

NCT05769517

BRCA Mutation Ovarian Cancer Ultrasound Therapy; Complications

RECRUITING

Study on Fertility Parameters in Women With Germline Variants in BRCA1 and BRCA2

NCT06710015

BRCA1 and/or BRCA2 Variant Carriers Fertility Reproductive Age +2 more

NOT_YET_RECRUITING

Feasibility Study of a Molecular Karyotype Using a Very High-throughput Sequencing Approach, the "Massive Parallel Sequencing" on Circulating Tumor DNA

NCT04104633

Breast Cancer Colo-rectal Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Women With BRCA1 Germline Deleterious Mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blood sampling

Group Type OTHER

Blood sampling

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No