Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation

NCT03667417 | Recruiting

• 1 other identifier: GENEPSO-IPC 2018-031
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers

Conditions

Breast Cancers; Ovarian Cancers

Keywords

BRCA gene mutation

Outcome Measures

Primary Outcomes (1)

• Incidence of breast and / or ovarian cancer during subject lifetime

  risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).

  10 years

Study Arms (1)

subjects carrying a BRCA gene mutation

subjects carrying a BRCA gene mutation

Other: Questionnaires

Interventions

Questionnaires OTHER

standardized data collection and 10-year prospective follow-up

subjects carrying a BRCA gene mutation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women and men with a BRCA1 or BRCA2 mutation

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead
• UNICANCER - Le Groupe génétique et cancer (GGC): collaborator

Study Sites (1)

Institut Paoli-Calmettes

Marseille, 13009, France

RECRUITING

Related Publications (59)

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• Lecarpentier J, Nogues C, Mouret-Fourme E, Gauthier-Villars M, Lasset C, Fricker JP, Caron O, Stoppa-Lyonnet D, Berthet P, Faivre L, Bonadona V, Buecher B, Coupier I, Gladieff L, Gesta P, Eisinger F, Frenay M, Luporsi E, Lortholary A, Colas C, Dugast C, Longy M, Pujol P, Tinat J; GENEPSO; Lidereau R, Andrieu N. Variation in breast cancer risk associated with factors related to pregnancies according to truncating mutation location, in the French National BRCA1 and BRCA2 mutations carrier cohort (GENEPSO). Breast Cancer Res. 2012 Jul 3;14(4):R99. doi: 10.1186/bcr3218.

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• GENEPSO : cohorte nationale prospective de personnes porteuses d'une mutation sur les gènes BRCA1 et BRCA2 GENEPSO: French BRCA1/2 carrier cohort study E. Fourme, C. Picard, M.L. Manche-Thévenot, C. Noguès, groupe Génétique et cancer* La Lettre du Sénologue • n° 43 - janvier-février-mars 2009

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• Bonaiti B, Alarcon F, Bonadona V, Pennec S, Andrieu N, Stoppa-Lyonnet D, Perdry H, Bonaiti-Pellie C; Groupe Genetique et Cancer. [A new scoring system for the diagnosis of BRCA1/2 associated breast-ovarian cancer predisposition]. Bull Cancer. 2011 Jul;98(7):779-95. doi: 10.1684/bdc.2011.1397. French.

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• Eisinger F, Bressac B, Castaigne D, Cottu PH, Lansac J, Lefranc JP, Lesur A, Nogues C, Pierret J, Puy-Pernias S, Sobol H, Tardivon A, Tristant H, Villet R. [Identification and management of hereditary predisposition to cancer of the breast and the ovary (update 2004)]. Bull Cancer. 2004 Mar;91(3):219-37. French.

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• Kuchenbaecker KB, Hopper JL, Barnes DR, Phillips KA, Mooij TM, Roos-Blom MJ, Jervis S, van Leeuwen FE, Milne RL, Andrieu N, Goldgar DE, Terry MB, Rookus MA, Easton DF, Antoniou AC; BRCA1 and BRCA2 Cohort Consortium; McGuffog L, Evans DG, Barrowdale D, Frost D, Adlard J, Ong KR, Izatt L, Tischkowitz M, Eeles R, Davidson R, Hodgson S, Ellis S, Nogues C, Lasset C, Stoppa-Lyonnet D, Fricker JP, Faivre L, Berthet P, Hooning MJ, van der Kolk LE, Kets CM, Adank MA, John EM, Chung WK, Andrulis IL, Southey M, Daly MB, Buys SS, Osorio A, Engel C, Kast K, Schmutzler RK, Caldes T, Jakubowska A, Simard J, Friedlander ML, McLachlan SA, Machackova E, Foretova L, Tan YY, Singer CF, Olah E, Gerdes AM, Arver B, Olsson H. Risks of Breast, Ovarian, and Contralateral Breast Cancer for BRCA1 and BRCA2 Mutation Carriers. JAMA. 2017 Jun 20;317(23):2402-2416. doi: 10.1001/jama.2017.7112.

  PMID: 28632866 RESULT

• Mancini J, Le Cozannet E, Bouhnik AD, Resseguier N, Lasset C, Mouret-Fourme E, Nogues C, Julian-Reynier C. Disclosure of research results: a randomized study on GENEPSO-PS cohort participants. Health Expect. 2016 Oct;19(5):1023-35. doi: 10.1111/hex.12390. Epub 2015 Jul 23.

  PMID: 26205609 RESULT

• Lecarpentier J, Nogues C, Mouret-Fourme E, Buecher B, Gauthier-Villars M, Stoppa-Lyonnet D, Bonadona V, Fricker JP, Berthet P, Caron O, Coupier I, Pujol P, Faivre L, Gesta P, Eisinger F, Mari V, Gladieff L, Lortholary A, Luporsi E, Leroux D, Venat-Bouvet L, Maugard CM, Colas C, Tinat J, Lasset C, Andrieu N; GENEPSO. Breast Cancer Risk Associated with Estrogen Exposure and Truncating Mutation Location in BRCA1/2 Carriers. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):698-707. doi: 10.1158/1055-9965.EPI-14-0884. Epub 2015 Jan 22.

  PMID: 25613119 RESULT

• Julian-Reynier C, Resseguier N, Bouhnik AD, Eisinger F, Lasset C, Fourme E, Nogues C. Cigarette smoking in women after BRCA1/2 genetic test disclosure: a 5-year follow-up study of the GENEPSO PS cohort. Genet Med. 2015 Feb;17(2):117-24. doi: 10.1038/gim.2014.82. Epub 2014 Jul 10.

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• Bureau E, Pellegrini I, Nogues C, Lasset C, Julian-Reynier C. "Maybe they have found something new" participants' views on returning cohort psychosocial survey results. Health Expect. 2015 Dec;18(6):2425-36. doi: 10.1111/hex.12211. Epub 2014 May 30.

  PMID: 24889689 RESULT

• Lapointe J, Dorval M, Nogues C, Fabre R; GENEPSO Cohort; Julian-Reynier C. Is the psychological impact of genetic testing moderated by support and sharing of test results to family and friends? Fam Cancer. 2013 Dec;12(4):601-10. doi: 10.1007/s10689-013-9621-3.

  PMID: 23475556 RESULT

• Pijpe A, Andrieu N, Easton DF, Kesminiene A, Cardis E, Nogues C, Gauthier-Villars M, Lasset C, Fricker JP, Peock S, Frost D, Evans DG, Eeles RA, Paterson J, Manders P, van Asperen CJ, Ausems MG, Meijers-Heijboer H, Thierry-Chef I, Hauptmann M, Goldgar D, Rookus MA, van Leeuwen FE; GENEPSO; EMBRACE; HEBON. Exposure to diagnostic radiation and risk of breast cancer among carriers of BRCA1/2 mutations: retrospective cohort study (GENE-RAD-RISK). BMJ. 2012 Sep 6;345:e5660. doi: 10.1136/bmj.e5660.

  PMID: 22956590 RESULT

• Eisinger F, Fabre R, Lasset C, Stoppa-Lyonnet D, Julian-Reynier C, Nogues C. Spontaneous disclosure of BRCA1/2 genetic test results to employers: a French prospective study. Eur J Hum Genet. 2012 Sep;20(9):981-3. doi: 10.1038/ejhg.2012.37. Epub 2012 Feb 29.

  PMID: 22378286 RESULT

• Pujol P, Lasset C, Berthet P, Dugast C, Delaloge S, Fricker JP, Tennevet I, Chabbert-Buffet N, This P, Baudry K, Lemonnier J, Roca L, Mijonnet S, Gesta P, Chiesa J, Dreyfus H, Vennin P, Delnatte C, Bignon YJ, Lortholary A, Prieur F, Gladieff L, Lesur A, Clough KB, Nogues C, Martin AL; French Federation of Cancer Centres (FNCLCC). Uptake of a randomized breast cancer prevention trial comparing letrozole to placebo in BRCA1/2 mutations carriers: the LIBER trial. Fam Cancer. 2012 Mar;11(1):77-84. doi: 10.1007/s10689-011-9484-4.

  PMID: 22076253 RESULT

• Lecarpentier J, Nogues C, Mouret-Fourme E, Stoppa-Lyonnet D, Lasset C, Caron O, Fricker JP, Gladieff L, Faivre L, Sobol H, Gesta P, Frenay M, Luporsi E, Coupier I; GENEPSO; Lidereau R, Andrieu N. Variation in breast cancer risk with mutation position, smoking, alcohol, and chest X-ray history, in the French National BRCA1/2 carrier cohort (GENEPSO). Breast Cancer Res Treat. 2011 Dec;130(3):927-38. doi: 10.1007/s10549-011-1655-3. Epub 2011 Jul 15.

  PMID: 21761160 RESULT

• Dorval M, Nogues C, Berthet P, Chiquette J, Gauthier-Villars M, Lasset C, Picard C, Plante M; INHERIT BRCAs; GENEPSO Cohort; Simard J, Julian-Reynier C. Breast and ovarian cancer screening of non-carriers from BRCA1/2 mutation-positive families: 2-year follow-up of cohorts from France and Quebec. Eur J Hum Genet. 2011 May;19(5):494-9. doi: 10.1038/ejhg.2010.227. Epub 2011 Jan 19.

  PMID: 21248744 RESULT

• Antoniou AC, Rookus M, Andrieu N, Brohet R, Chang-Claude J, Peock S, Cook M, Evans DG, Eeles R; EMBRACE; Nogues C, Faivre L, Gesta P; GENEPSO; van Leeuwen FE, Ausems MG, Osorio A; GEO-HEBON; Caldes T, Simard J, Lubinski J, Gerdes AM, Olah E, Furhauser C, Olsson H, Arver B, Radice P, Easton DF, Goldgar DE. Reproductive and hormonal factors, and ovarian cancer risk for BRCA1 and BRCA2 mutation carriers: results from the International BRCA1/2 Carrier Cohort Study. Cancer Epidemiol Biomarkers Prev. 2009 Feb;18(2):601-10. doi: 10.1158/1055-9965.EPI-08-0546. Epub 2009 Feb 3.

  PMID: 19190154 RESULT

• Brohet RM, Goldgar DE, Easton DF, Antoniou AC, Andrieu N, Chang-Claude J, Peock S, Eeles RA, Cook M, Chu C, Nogues C, Lasset C, Berthet P, Meijers-Heijboer H, Gerdes AM, Olsson H, Caldes T, van Leeuwen FE, Rookus MA. Oral contraceptives and breast cancer risk in the international BRCA1/2 carrier cohort study: a report from EMBRACE, GENEPSO, GEO-HEBON, and the IBCCS Collaborating Group. J Clin Oncol. 2007 Sep 1;25(25):3831-6. doi: 10.1200/JCO.2007.11.1179. Epub 2007 Jul 16.

  PMID: 17635951 RESULT

• Chang-Claude J, Andrieu N, Rookus M, Brohet R, Antoniou AC, Peock S, Davidson R, Izatt L, Cole T, Nogues C, Luporsi E, Huiart L, Hoogerbrugge N, Van Leeuwen FE, Osorio A, Eyfjord J, Radice P, Goldgar DE, Easton DF; Epidemiological Study of Familial Breast Cancer (EMBRACE); Gene Etude Prospective Sein Ovaire (GENEPSO); Genen Omgeving studie van de werkgroep Hereditiair Borstkanker Onderzoek Nederland (GEO-HEBON); International BRCA1/2 Carrier Cohort Study (IBCCS) collaborators group. Age at menarche and menopause and breast cancer risk in the International BRCA1/2 Carrier Cohort Study. Cancer Epidemiol Biomarkers Prev. 2007 Apr;16(4):740-6. doi: 10.1158/1055-9965.EPI-06-0829.

  PMID: 17416765 RESULT

• Andrieu N, Goldgar DE, Easton DF, Rookus M, Brohet R, Antoniou AC, Peock S, Evans G, Eccles D, Douglas F, Nogues C, Gauthier-Villars M, Chompret A, Van Leeuwen FE, Kluijt I, Benitez J, Arver B, Olah E, Chang-Claude J; EMBRACE; GENEPSO; GEO-HEBON; IBCCS Collaborators Group. Pregnancies, breast-feeding, and breast cancer risk in the International BRCA1/2 Carrier Cohort Study (IBCCS). J Natl Cancer Inst. 2006 Apr 19;98(8):535-44. doi: 10.1093/jnci/djj132.

  PMID: 16622123 RESULT

• Jegu M, Some Der A, Morcel K, Abadie C, Fritel X, Leveque J. [Breast and ovarian cancer due to BRCA1&2 hereditary cancer predisposition syndrome and reproduction: literature review]. J Gynecol Obstet Biol Reprod (Paris). 2015 Jan;44(1):10-7. doi: 10.1016/j.jgyn.2014.10.011. Epub 2014 Nov 18. French.

  PMID: 25455630 RESULT

• Feunteun J. [A paradox and three egnimas about the role of BRCA1 in breast and ovarian cancers]. J Soc Biol. 2004;198(2):123-6. French.

  PMID: 15368961 RESULT

• Suivi prospectif à 5 ans des tests de prédisposition génétique au cancer du sein et/ou de l'ovaire : comportements de prévention, attentes envers la recherche et inégalités sociales (cohorte nationale Genepso) Institut National du Cancer (INCa) dans le cadre de l'appel à projets 2011 Projets libres de recherché en sciences humaines et sociales, épidémiologie et santé publique.

  RESULT

• Bonaiti-Pellie C, Andrieu N, Arveux P, Bonadona V, Buecher B, Delpech M, Jolly D, Julian-Reynier C, Luporsi E, Nogues C, Nowak F, Olschwang S, Orsi F, Pujol P, Saurin JC, Sinilnikova O, Stoppa-Lyonnet D, Thepot F. [Cancer genetics: estimation of the needs of the population in France for the next ten years]. Bull Cancer. 2009 Sep;96(9):875-900. doi: 10.1684/bdc.2009.0943. French.

  PMID: 19751997 RESULT

Related Links

• Description de la cohorte GENEPSO au sein du Portail Epidémiologie-France

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine NOGUES, MD

  Institut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

33 491 22 37 78; DRCI.UP@ipc.unicancer.fr

Margot BERLINE, MSc, MBA

CONTACT

33 491 22 33 14; DRCI.UP@ipc.unicancer.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: October 15, 1999
• Primary Completion (Estimated): October 15, 2028
• Study Completion (Estimated): October 15, 2028
• Last Updated: July 1, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)