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An Exploration of Genetic Testing for Prostate Cancer Susceptibility

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institute of Cancer Research, United Kingdom
Information provided by:
Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00997464
First received: October 16, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition
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:

U.S. FDA Resources

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) [ Designated as safety issue: No ]

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? [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]
  • Is there a relationship between a family history of cancer, cancer worry, and a persons intention to seek genetic testing? [ Designated as safety issue: No ]
  • 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 [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   40 Years to 69 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men with strong family history of prostate cancer.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00997464

Contacts
Contact: Dr Rosalind Eeles 02086613642 rosalind.eeles@icr.ac.uk
Contact: Elizabeth Bancroft 02086612136 elizabeth.bancroft@rmh.nhs.uk

Locations
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
Investigators
Principal Investigator: Dr Rosalind Eeles Institute of Cancer Research, United Kingdom
  More Information

No publications provided

Responsible Party: Dr. Rosalind Eeles, Institute of Cancer Research
ClinicalTrials.gov Identifier: NCT00997464     History of Changes
Other Study ID Numbers: CCR3200
Study First Received: October 16, 2009
Last Updated: October 16, 2009
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Prostatic Neoplasms
Disease Attributes
Pathologic Processes
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013