- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00897455
Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.
PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
Aperçu de l'étude
Statut
Description détaillée
OBJECTIVES:
- To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).
OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892-1182
- Recrutement
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
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Contact:
- Clinical Trials Office - Warren Grant Magnusen Clinical Center
- Numéro de téléphone: 888-NCI-1937
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
- Known positive BRCA1/BRCA2 mutation carrier
- With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199
Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:
- Completed baseline questionnaire (BQ-199)
- Provided information on prior breast cancer history, including date of diagnosis
- Provided complete data from the DNA analysis on the genetic variants of interest
- Signed an approved informed consent and authorization permitting release of personal health information
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Plan d'étude
Comment l'étude est-elle conçue ?
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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Identification of potential genetic modifiers of breast cancer risk
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Mark H. Greene, MD, Clinical Genetics Branch
- Michael Birrer, MD, PhD, NCI - Cell and Cancer Biology Branch
- Phuong Mai, MD, Clinical Genetics Branch
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CDR0000598427
- GOG-8008
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer du sein
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AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie