NCT00997464

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 19, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

October 19, 2009

Status Verified

October 1, 2009

Enrollment Period

1.5 years

First QC Date

October 16, 2009

Last Update Submit

October 16, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

  • 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

Eligibility Criteria

Age40 Years - 69 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Men with strong family history of prostate cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Dr Rosalind Eeles

    Institute of Cancer Research, United Kingdom

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 16, 2009

First Posted

October 19, 2009

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

October 19, 2009

Record last verified: 2009-10

Locations