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 - Full Text View

Sponsored by:	University of Cambridge Cancer Research UK
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00758173

Purpose

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.

Condition	Intervention
Prostate Cancer	Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: questionnaire administration

Study Type:	Observational
Official Title:	A Population Based Study of Genetic Predisposition and Gene-Environment Interactions in Prostate Cancer in East Anglia, Trent and West Midlands

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Acquisition of epidemiological information and biological material [ Designated as safety issue: No ]
Identification of novel cancer susceptibility genes [ Designated as safety issue: No ]
Estimation of the age and sex-specific risks associated with variants in predisposition genes [ Designated as safety issue: No ]
Evaluation interactions between polymorphisms in predisposition genes and potential lifestyle risk factors [ Designated as safety issue: No ]

Estimated Enrollment:	2000
Study Start Date:	February 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 74 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00758173

Locations

United Kingdom, England
University of Cambridge Cancer Research UK	Recruiting
Cambridge, England, United Kingdom, CB1 8RN
Contact: Contact Person 44-122-374-0166 paul.pharoah@srl.cam.ac.uk

Sponsors and Collaborators

University of Cambridge Cancer Research UK

Investigators

Study Chair:

Paul Pharoah, MD

University of Cambridge Cancer Research UK

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000589199, MREC-SEARCH-PROSTATE
Study First Received:	September 22, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00758173 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Disease Susceptibility
Urogenital Neoplasms

Genetic Predisposition to Disease
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009