Blood Samples From Healthy Volunteers for Genetic Studies in the East Anglia Region 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:	NCT00757991

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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

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

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:	CDR0000598880, MREC-SEARCH-CONTROL, MREC-07/MRE05/17
Study First Received:	September 22, 2008
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00757991 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

healthy, no evidence of disease

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009