An Exploration of Genetic Testing for Prostate Cancer Susceptibility

NCT ID: NCT00997464

Last Updated: 2009-10-19

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2011-02-28

Brief Summary

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Study of the factors that affect interest in - and uptake of - genetic testing for variants that predispose to prostate cancer from the perspective of the patient.

Detailed Description

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This study will use a mixed methods approach to follow men as they move through the genetic testing process, from initial contact through to receiving their genetic testing results. A questionnaire will be used to measure variables at both baseline and after proceeding through the testing process. A small cohort of men will be invited to be interviewed to gather some in depth qualitative data about the issues that have arisen during the study process.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Men with a positive family history of prostate cancer. The definition of a positive family history will be: Men with a first degree relative with prostate cancer diagnosed at \<70 years; Men with two relatives with prostate cancer where at least on is diagnosed at \<70 years; Men with three relatives with prostate cancer diagnosed at any age
* Age 40-69 years
* No previous biopsy for raised PSA
* Absence of any psychological, familial, sociological or geographic situation potentially hampering compliance with the study protocol and follow-up schedule.

Exclusion Criteria

* Previous prostate cancer
* Men from families where there is known to be a mutation in a high-risk prostate cancer gene
* Men who have had a prostate biopsy within the last 12 months.
Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role collaborator

Responsible Party

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Institute of Cancer Research

Principal Investigators

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Dr Rosalind Eeles

Role: PRINCIPAL_INVESTIGATOR

Institute of Cancer Research, United Kingdom

Locations

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Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Dr Rosalind Eeles

Role: CONTACT

02086613642

Elizabeth Bancroft

Role: CONTACT

02086612136

Other Identifiers

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CCR3200

Identifier Type: -

Identifier Source: org_study_id

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