An Exploration of Genetic Testing for Prostate Cancer Susceptibility
October 16, 2009 updated by: Royal Marsden NHS Foundation Trust
An Exploration of Factors Affecting Interest and Uptake of Genetic Testing for Prostate Cancer Susceptibility: The Clinical Application of Genetic Testing for Lower Risk Cancer Predisposition Genes
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Surrey
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Sutton, Surrey, United Kingdom, SM2 5PT
- Recruiting
- Royal Marsden NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Men with strong family history of prostate cancer.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale)
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Secondary Outcome Measures
Outcome Measure |
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Why are men interested/ not interested in seeking genetic profiling for prostate cancer, and what might be the uptake of such testing?
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What are the expectations of this testing from the perspective of the user, what are the perceived benefits and limitations of testing and how do these change through the testing process
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Is there a relationship between a family history of cancer, cancer worry, and a persons intention to seek genetic testing?
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How would the information provided by such a test be used by the individual and the family and how could this impact upon the healthcare system
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Dr Rosalind Eeles, Institute of Cancer Research, United Kingdom
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
October 16, 2009
First Submitted That Met QC Criteria
October 16, 2009
First Posted (Estimate)
October 19, 2009
Study Record Updates
Last Update Posted (Estimate)
October 19, 2009
Last Update Submitted That Met QC Criteria
October 16, 2009
Last Verified
October 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCR3200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.