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An Exploration of Genetic Testing for Prostate Cancer Susceptibility

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was:  Recruiting
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust Identifier:
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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.

Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale)

Secondary Outcome Measures:
  • Why are men interested/ not interested in seeking genetic profiling for prostate cancer, and what might be the uptake of such testing?
  • 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
  • Is there a relationship between a family history of cancer, cancer worry, and a persons intention to seek genetic testing?
  • 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

Estimated Enrollment: 200
Study Start Date: August 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   40 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men with strong family history of prostate cancer.

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00997464

Contact: Dr Rosalind Eeles 02086613642
Contact: Elizabeth Bancroft 02086612136

United Kingdom
Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Institute of Cancer Research, United Kingdom
Principal Investigator: Dr Rosalind Eeles Institute of Cancer Research, United Kingdom
  More Information

Responsible Party: Dr. Rosalind Eeles, Institute of Cancer Research Identifier: NCT00997464     History of Changes
Other Study ID Numbers: CCR3200
Study First Received: October 16, 2009
Last Updated: October 16, 2009

Additional relevant MeSH terms:
Prostatic Neoplasms
Disease Susceptibility
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Disease Attributes
Pathologic Processes processed this record on May 25, 2017