Recruiting NCT03667417
Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Questionnaires.
- Who it may be relevant to
- Registry conditions: Breast Cancers, Ovarian Cancers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
Detailed description
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
Interventions
- Other Questionnaires
standardized data collection and 10-year prospective follow-up
Primary outcome measures
- Incidence of breast and / or ovarian cancer during subject lifetime [Time frame: 10 years]
Eligibility criteria
- Woman or man, with or without cancer, carrying a deleterious BRCA1/BRCA2 mutation, aged 18 years and over.
- Woman with or without breast cancer or ovarian cancer at baseline.
- Man with or without breast cancer at baseline.
- Signed consent to participation
- Affiliation to a social security regimen, or beneficiary of such a regimen.
Exclusion criteria
- A person of legal age subject to a legal protection measure, or unable to express consent.
- Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Institut Paoli-Calmettes — Marseille
Publications
- Pathology of familial breast cancer: differences between breast cancers in carriers of BRCA1 or BRCA2 mutations and sporadic cases. Breast Cancer Linkage Consortium. Lancet. 1997 May 24;349(9064):1505-10. PMID 9167459
- Brzovic PS, Meza J, King MC, Klevit RE. The cancer-predisposing mutation C61G disrupts homodimer formation in the NH2-terminal BRCA1 RING finger domain. J Biol Chem. 1998 Apr 3;273(14):7795-9. doi: 10.1074/jbc.273.14.7795. PMID 9525870
- Claus EB, Risch N, Thompson WD. Genetic analysis of breast cancer in the cancer and steroid hormone study. Am J Hum Genet. 1991 Feb;48(2):232-42. PMID 1990835
- Couch FJ, Weber BL. Mutations and polymorphisms in the familial early-onset breast cancer (BRCA1) gene. Breast Cancer Information Core. Hum Mutat. 1996;8(1):8-18. doi: 10.1002/humu.1380080102. PMID 8807330
- Den Otter W, Merchant TE, Beijerinck D, Koten JW. Breast cancer induction due to mammographic screening in hereditarily affected women. Anticancer Res. 1996 Sep-Oct;16(5B):3173-5. PMID 8967731
- Easton DF, Ford D, Bishop DT. Breast and ovarian cancer incidence in BRCA1-mutation carriers. Breast Cancer Linkage Consortium. Am J Hum Genet. 1995 Jan;56(1):265-71. PMID 7825587
- Easton D. Breast cancer genes--what are the real risks? Nat Genet. 1997 Jul;16(3):210-1. doi: 10.1038/ng0797-210. No abstract available. PMID 9207777
- Eisinger F, Thouvenin D, Bignon YJ, Cuisenier J, Feingold J, Hoerni B, Lasset C, Lyonnet D, Maraninchi D, Marty M, et al. [Considerations on the organization of oncologic-genetic consultations (a first step towards the publication of clinical practice guidelines)]. Bull Cancer. 1995 Oct;82(10):865-78. No abstract available. French. PMID 8535012
Identifiers
NCT: NCT03667417 · GENEPSO-IPC 2018-031