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

NCT02608346 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-31

No results posted yet for this study

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 (CTC) performed at each hospital visit (for technical reason only patients included at Institut Curie will be proposed to participate to the CTC substudy).

Conditions

  • Women With BRCA1 Germline Deleterious Mutation

Interventions

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

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Jean-Yves PIERGA, DR · Institut Curie

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2021-12-29
Completion
2021-12-29

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02608346 on ClinicalTrials.gov