Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom
Primary Purpose
Prostate 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 Prostate Cancer focused on measuring prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer within the past 5 years
Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:
- East Anglia
- 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
Sites / Locations
- University of Cambridge Cancer Research UKRecruiting
Outcomes
Primary Outcome Measures
Acquisition of epidemiological information and biological material
Identification of novel cancer susceptibility genes
Estimation of the age and sex-specific risks associated with variants in predisposition genes
Evaluation interactions between polymorphisms in predisposition genes and potential lifestyle risk factors
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00758173
Brief Title
Study of Genes and the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom
Official Title
A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Prostate Cancer in East Anglia, Trent and West Midlands
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 and the interactions between genes and the environment in patients with prostate cancer.
Detailed Description
OBJECTIVES:
To obtain epidemiological information and biological material on a population-based series of prostate cancer cases.
To identify novel cancer susceptibility genes by comparison of genotype frequencies in cases with the corresponding frequencies in large control series.
To estimate the age and sex-specific risks associated with variants in predisposition genes.
To evaluate interactions between polymorphisms in predisposition genes and potential lifestyle risk factors.
OUTLINE: This is a multicenter study.
Patients complete a detailed epidemiological questionnaire, including information on education, occupation, smoking habits, alcohol consumption, height, weight, family history of cancer, and past medical history.
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 prostate cancer patients recruited for this study, patients with breast, ovarian, endometrial, 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-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer
7. Study Design
Enrollment
2000 (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
Identification of novel cancer susceptibility genes
Title
Estimation of the age and sex-specific risks associated with variants in predisposition genes
Title
Evaluation interactions between polymorphisms in predisposition genes and potential lifestyle risk factors
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer within the past 5 years
Identified through the cancer registry serving any of the following geographic regions of the United Kingdom:
East Anglia
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
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 the Environment in Patients With Prostate Cancer Residing in the East Anglia, Trent, or West Midlands Regions of the United Kingdom
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