Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom

NCT ID: NCT00757211

Last Updated: 2013-08-26

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

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* 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.

Conditions

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Breast Cancer

Keywords

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breast cancer male breast cancer

Interventions

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polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer within the past 5 years
* Identified through the East Anglian Cancer Registry in the East Anglia region of the United Kingdom
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Menopausal status not specified
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Paul Pharoah, MD

Role: STUDY_CHAIR

Cancer Research UK

Locations

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University of Cambridge Cancer Research UK

Cambridge, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Contact Person

Role: primary

Other Identifiers

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MREC-SEARCH-BREAST

Identifier Type: -

Identifier Source: secondary_id

MREC-07/MRE05/17

Identifier Type: -

Identifier Source: secondary_id

CDR0000598878

Identifier Type: -

Identifier Source: org_study_id