Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation
NCT ID: NCT03667417
Last Updated: 2020-07-01
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
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Recruitment Status
RECRUITING
Total Enrollment
5000 participants
Study Classification
OBSERVATIONAL
Study Start Date
1999-10-15
Study Completion Date
2028-10-15
Brief Summary
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Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
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Detailed Description
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Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
Conditions
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Breast Cancers
Ovarian Cancers
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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subjects carrying a BRCA gene mutation
subjects carrying a BRCA gene mutation
Questionnaires
Intervention Type
OTHER
standardized data collection and 10-year prospective follow-up
Interventions
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Questionnaires
standardized data collection and 10-year prospective follow-up
Intervention Type
OTHER
Eligibility Criteria
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Exclusion Criteria
1. A person of legal age subject to a legal protection measure, or unable to express consent.
2. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
2. Impossibility to submit to the follow-up of the test for geographical, social or psychological reasons
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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UNICANCER - Le Groupe génétique et cancer (GGC)
UNKNOWN
Sponsor Role
collaborator
Institut Paoli-Calmettes
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Catherine NOGUES, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Paoli-Calmettes
Locations
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Institut Paoli-Calmettes
Marseille, , France
Site Status
RECRUITING
Countries
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France
Central Contacts
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Facility Contacts
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References
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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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RESULT
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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Related Links
Access external resources that provide additional context or updates about the study.
https://epidemiologie-france.aviesan.fr/epidemiologie-france/fiches/cohorte-de-sujets-portant-une-mutation-des-genes-brca-predispositions-genetiques-aux-cancers-du-sein-et-de-l-ovaire/fre-fr
Description de la cohorte GENEPSO au sein du Portail Epidémiologie-France
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GENEPSO-IPC 2018-031
Identifier Type: -
Identifier Source: org_study_id
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