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

NCT ID: NCT00757991

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy, no Evidence of Disease

Keywords

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healthy, no evidence of disease

Interventions

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polymorphism analysis

Intervention Type GENETIC

laboratory biomarker analysis

Intervention Type OTHER

questionnaire administration

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

35 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Paul Pharoah, MD

Role: STUDY_CHAIR

Cancer Research UK

Locations

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University of Cambridge Cancer Research UK

Cambridge, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Contact Person

Role: primary

Other Identifiers

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MREC-SEARCH-CONTROL

Identifier Type: -

Identifier Source: secondary_id

MREC-07/MRE05/17

Identifier Type: -

Identifier Source: secondary_id

CDR0000598880

Identifier Type: -

Identifier Source: org_study_id