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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00757991
First received: September 22, 2008
Last updated: August 23, 2013
Last verified: September 2008
  Purpose

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.


Condition Intervention
Healthy, no Evidence of Disease
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
Other: questionnaire administration

Study Type: Observational
Official Title: A Population Based Control Collection for Genetic Studies in East Anglia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Acquisition of blood samples and epidemiological information [ Designated as safety issue: No ]
  • Investigation of whether polymorphisms in putative cancer predisposition genes are associated with an increased risk of cancer [ Designated as safety issue: No ]
  • Examination of the interactions between genetic and nongenetic risk factors [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: February 2008
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.

  Eligibility

Ages Eligible for Study:   35 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757991

Locations
United Kingdom
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
Cancer Research UK
Investigators
Study Chair: Paul Pharoah, MD Cancer Research UK
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00757991     History of Changes
Other Study ID Numbers: CDR0000598880, MREC-SEARCH-CONTROL, MREC-07/MRE05/17
Study First Received: September 22, 2008
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
healthy, no evidence of disease

ClinicalTrials.gov processed this record on July 26, 2014