Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Locations
United Kingdom
Study Type
Observational
Intervention
polymorphism analysis
laboratory biomarker analysis
questionnaire administration
Sponsored by
About this trial
This is an observational trial for Breast Cancer focused on measuring breast cancer, male breast cancer
Eligibility 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
Sites / Locations
- University of Cambridge Cancer Research UKRecruiting
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00757211
Brief Title
Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
Official Title
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Breast Cancer in East Anglia
Study Type
Observational
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Cancer Research UK
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, male breast cancer
7. Study Design
Enrollment
6000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Genetic
Intervention Name(s)
polymorphism analysis
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Primary Outcome Measure Information:
Title
Acquisition of epidemiological information and biological material
Title
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of breast cancer
Title
Proportion of breast cancer incidence attributable to mutations in such genes
Title
Examination of the interactions between genetic and nongenetic risk factors
Title
Evaluation of the relationship between pathological and clinical characteristics of breast cancers and germline genotype
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Pharoah, MD
Organizational Affiliation
Cancer Research UK
Official's Role
Study Chair
Facility Information:
Facility Name
University of Cambridge Cancer Research UK
City
Cambridge
State/Province
England
ZIP/Postal Code
CB1 8RN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Contact Person
Phone
44-122-374-0166
Email
paul.pharoah@srl.cam.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Study of Genes and Environment in Patients With Breast Cancer in the East Anglia Region of the United Kingdom
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