- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00757263
Study of Genes and the Environment in Patients With Ovarian Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Ovarian Cancer in East Anglia, Oxford, Trent and West Midlands
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This study is looking at genetic susceptibility for cancer and interactions between genes and the environment in patients with ovarian cancer.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
OBJECTIVES:
- To obtain epidemiological information and biological material on a population-based series of ovarian cases.
- To define the proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2).
- To determine the risk associated with predisposing mutations by examining the cancer risks in relatives of patients who are shown to be carriers.
- To examine the effect of nongenetic risk factors in mutation carriers.
- To determine the pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers.
- To establish whether mutations at other loci may predispose to ovarian cancer by comparing the frequency of alterations in ovarian cancer patients with that in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire. The questionnaire will request identifying information on the patient's first-degree relatives.
Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.
In addition to the ovarian cancer patients recruited for this study, patients with breast, endometrial, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.
Tipo de estudio
Inscripción (Anticipado)
Contactos y Ubicaciones
Ubicaciones de estudio
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England
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Cambridge, England, Reino Unido, CB1 8RN
- Reclutamiento
- University of Cambridge Cancer Research UK
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Contacto:
- Contact Person
- Número de teléfono: 44-122-374-0166
- Correo electrónico: paul.pharoah@srl.cam.ac.uk
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
- Diagnosis of ovarian cancer within the past 5 years
Identified through the East Anglia, Stoke and West Midlands Cancer Registries serving any of the following geographic regions of the United Kingdom:
- East Anglia
- Oxford
- Trent
- West Midlands
PATIENT CHARACTERISTICS:
- Identified by the patient's general practitioner as fit to contact for this study
- No serious mental illness or retardation
PRIOR CONCURRENT THERAPY:
- Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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Adquisición de información epidemiológica y material biológico
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Proportion of ovarian cancer incidence attributable to mutations in known predisposing genes (e.g., BRCA1 and BRCA2)
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Risk associated with predisposing mutations
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Effect of nongenetic risk factors in mutation carriers
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Pathological and clinical characteristics of ovarian cancers occurring in BRCA1/2 mutation carriers as compared with that in noncarriers
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Exploration of mutations at other loci that may predispose to ovarian cancer
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Paul Pharoah, MD, Cancer Research UK
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias urogenitales
- Neoplasias por sitio
- Carcinoma
- Neoplasias Glandulares y Epiteliales
- Neoplasias Genitales Femeninas
- Enfermedades del sistema endocrino
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Neoplasias de glándulas endocrinas
- Neoplasias Ováricas
- Carcinoma Epitelial De Ovario
Otros números de identificación del estudio
- CDR0000598881
- MREC-07/MRE05/17
- MREC-SEARCH-OVARIAN
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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