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

NCT02608346 | Completed DMC

• 1 other identifier: IC 2014-05
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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

Keywords

Circulating tumor DNA; BRCA1 mutation; Circulating tumor cells

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Up to 42 months

Secondary Outcomes (6)

• Positive predictive value for mutated TP53 ctDNA

  Up to 42 months

• Negative predictive value for mutated TP53 ctDNA

  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

  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

  Up to 42 months

• Positive predictive value for circulating tumor cells

  Up to 42 months

Study Arms (1)

Blood sampling

OTHER

Procedure: Blood sampling

Interventions

Blood sampling 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

Blood sampling

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (4)

Centre Léon Bérard

Lyon, 69273, France

Location

Institut Curie

Paris, 75005, France

Location

Hôpital René Huguenin - Institut Curie

Saint-Cloud, 92210, France

Location

Institut Gustave ROUSSY

Villejuif, 94805, France

Location

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jean-Yves PIERGA, DR

  Institut Curie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 18, 2015
• Study Start: November 1, 2014
• Primary Completion: December 29, 2021
• Study Completion: December 29, 2021
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months
• Access Criteria: Access to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

Locations

FR (4)