Genetic Predisposition to Breast and Ovarian Cancer: Prospective Study of BRCAx Gene Mutation (GENEPSO)
2020年6月30日 更新者：Institut Paoli-Calmettes
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
研究概览
详细说明
Cohort of subjects carrying a BRCA gene mutation: genetic predispositions to breast and ovarian cancers
研究类型
观察性的
注册 (预期的)
5000
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Dominique GENRE, MD
- 电话号码：33 491 22 37 78
- 邮箱：DRCI.UP@ipc.unicancer.fr
研究联系人备份
- 姓名：Margot BERLINE, MSc, MBA
- 电话号码：33 491 22 33 14
- 邮箱：DRCI.UP@ipc.unicancer.fr
学习地点
-
-
-
Marseille、法国、13009
- 招聘中
- Institut Paoli-Calmettes
-
接触：
- Catherine NOGUES, MD
- 电话号码：334 91 223395
- 邮箱：NOGUESC@ipc.unicancer.fr
-
首席研究员：
- Catherine NOGUES, MD
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
women and men with a BRCA1 or BRCA2 mutation
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
subjects carrying a BRCA gene mutation
|
standardized data collection and 10-year prospective follow-up
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of breast and / or ovarian cancer during subject lifetime
大体时间：10 years
|
risk that a subject with a mutation develops breast and / or ovarian cancer during his lifetime, assessed by epidemiologic questionnaires (carcinologic events).
|
10 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Catherine NOGUES, MD、Institut Paoli-Calmettes
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- 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.
- 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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- 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.
- 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.
- 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.
- 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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- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
1999年10月15日
初级完成 (预期的)
2028年10月15日
研究完成 (预期的)
2028年10月15日
研究注册日期
首次提交
2018年9月10日
首先提交符合 QC 标准的
2018年9月11日
首次发布 (实际的)
2018年9月12日
研究记录更新
最后更新发布 (实际的)
2020年7月1日
上次提交的符合 QC 标准的更新
2020年6月30日
最后验证
2020年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- GENEPSO-IPC 2018-031
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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