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

A Population Based Control Collection for Genetic Studies in East Anglia

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.

Study Overview

• Status: Unknown
• Conditions: Healthy, no Evidence of Disease
• Intervention / Treatment: Genetic: polymorphism analysis; Other: laboratory biomarker analysis; Other: questionnaire administration

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 4000

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Acquisition of blood samples and epidemiological information
Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer
Examination of the interactions between genetic and nongenetic risk factors

Collaborators and Investigators

• Sponsor: Cancer Research UK
• Investigators: Study Chair: Paul Pharoah, MD, Cancer Research UK

Study record dates

Study Major Dates

• Study Start: February 1, 2008

Study Registration Dates

• First Submitted: September 22, 2008
• First Submitted That Met QC Criteria: September 22, 2008
• First Posted (Estimate): September 23, 2008

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: healthy, no evidence of disease
• Other Study ID Numbers: CDR0000598880; MREC-SEARCH-CONTROL; MREC-07/MRE05/17