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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00758173
• Other study ID #: CDR0000589199
• Secondary ID: MREC-SEARCH-PROS
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2008
• Last updated: August 23, 2013
• Start date: February 2008

Study information

• Verified date: September 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

• questionnaire administration

Locations

Country	Name	City	State
United Kingdom	University of Cambridge Cancer Research UK	Cambridge	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acquisition of epidemiological information and biological material			No
Primary	Identification of novel cancer susceptibility genes			No
Primary	Estimation of the age and sex-specific risks associated with variants in predisposition genes			No
Primary	Evaluation interactions between polymorphisms in predisposition genes and potential lifestyle risk factors			No