Blood Samples From Healthy Volunteers for Genetic Studies... | NCT00757991

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

NCT00757991

Sponsor

Cancer Research UK

Status

Unknown status

Last Update Posted

Aug 26, 2013Estimated

Enrollment

4,000Estimated

Phase

Not provided

Conditions

Healthy, no Evidence of Disease

Interventions

polymorphism analysis
laboratory biomarker analysis
questionnaire administration

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 22, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2013

Last Update Posted Date

Aug 26, 2013Estimated

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

4,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

69 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Pharoah, MD	Cancer Research UK	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Cambridge Cancer Research UK	Recruiting	Cambridge	England	CB1 8RN	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
D054458	Amplified Fragment Length Polymorphism Analysis

Ancestor Terms

ID	Term
D016172	DNA Fingerprinting
D005821	Genetic Techniques
D008919	Investigative Techniques
D016133	Polymerase Chain Reaction

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
polymorphism analysis	Genetic
laboratory biomarker analysis	Other
questionnaire administration	Other

ID	Type	Description	Link
MREC-SEARCH-CONTROL
MREC-07/MRE05/17