Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
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|ClinicalTrials.gov Identifier: NCT00757211|
Recruitment Status : Unknown
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : September 23, 2008
Last Update Posted : August 26, 2013
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 to cancer and interactions between genes and the environment in patients with breast cancer.
|Condition or disease||Intervention/treatment|
|Breast Cancer||Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: questionnaire administration|
- To obtain epidemiological information and biological material on a population-based series of breast cancer cases.
- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer by comparing the frequency of alterations in breast cancer patients with the corresponding frequency in controls.
- To define the proportion of breast cancer incidence attributable to mutations in such genes.
- To examine the interactions between genetic and nongenetic risk factors.
- To evaluate the relationship between pathological and clinical characteristics of breast cancers and germline genotype.
OUTLINE: This is a multicenter study.
Patients complete an epidemiological questionnaire that covers standard known breast cancer risk factors including reproductive history, oral contraceptive use, hormone replacement therapy use, family history, and alcohol consumption. The questionnaire will also request identifying information on the patient's first-degree relatives.
Blood samples are collected from patients. DNA is extracted from these blood samples, from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL, and 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 breast cancer patients recruited for this study, patients with malignant melanoma and lymphoma, colorectal, ovarian, prostate, colorectal, bladder, kidney, pancreatic, and esophageal cancer, and brain tumors are recruited for the following related clinical trials: MREC-SEARCH-COLORECTAL, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-ENDOMETRIAL, and MREC-SEARCH-CANCER.
|Study Type :||Observational|
|Estimated Enrollment :||6000 participants|
|Official Title:||A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast Cancer in East Anglia|
|Study Start Date :||February 2008|
- Acquisition of epidemiological information and biological material
- Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer
- Proportion of breast cancer incidence attributable to mutations in such genes
- Examination of the interactions between genetic and nongenetic risk factors
- Evaluation of the relationship between pathological and clinical characteristics of breast cancers and germline genotype
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00757211
|University of Cambridge Cancer Research UK||Recruiting|
|Cambridge, England, United Kingdom, CB1 8RN|
|Contact: Contact Person 44-122-374-0166 email@example.com|
|Study Chair:||Paul Pharoah, MD||Cancer Research UK|