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NCT00757991 Clinical Trial

Blood Samples From Healthy Volunteers for Genetic Studies in the East Anglia Region of the United Kingdom

Healthy, no Evidence of Disease Clinical Trial

Official title:
A Population Based Control Collection for Genetic Studies in East Anglia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00757991
Other study ID # CDR0000598880
Secondary ID MREC-SEARCH-CONT
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 healthy volunteers 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 healthy volunteers.

Description:

OBJECTIVES:

- To obtain blood samples and simple epidemiological information on a population-based series of adult individuals without cancer.

- To establish whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer by comparing the frequency of alterations in these genes with the corresponding frequency in a comparable series of cancer patients.

- To examine the interactions between genetic and non-genetic risk factors.

OUTLINE: This is a multicenter study.

Participants complete a simple epidemiological questionnaire.

Participants undergo blood sample collection. DNA is extracted from these samples for polymorphism analysis of low penetrance cancer susceptibility genes in the following related clinical trials: MREC-SEARCH-CANCER, MREC-SEARCH-PROSTATE, and MREC-SEARCH-BREAST. They may also be used in the analyses of the following related clinical trials: MREC-SEARCH-OVARIAN, MREC-SEARCH-ENDOMETRIAL, MREC-SEARCH-COLORECTAL.

PROJECTED ACCRUAL: A total of 2,000 male and 2,000 female participants will be accrued for this study.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 35 Years to 69 Years
Eligibility DISEASE CHARACTERISTICS:

- Cancer-free participants randomly selected from the age-sex registry of a general practice in the East Anglia region of the United Kingdom

- Two general practices from each district within East Anglia participate (up to 10 total participating practices)

PATIENT CHARACTERISTICS:

- Identified by the participant's general practitioner as fit to contact for this study

- No prior diagnosis of cancer

- No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

N/A

Related Conditions & MeSH terms

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 blood samples and epidemiological information No
Primary Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer No
Primary Examination of the interactions between genetic and nongenetic risk factors No
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