Prostate CancerNCT00997464
An Exploration of Genetic Testing for Prostate Cancer Susceptibility
An observational study of Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Men with strong family history of prostate cancer.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Investigators
- Dr Rosalind Eeles, Principal investigator, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00997464
- Sponsor's protocol ID
- CCR3200
- Status last verified
- Oct 2009
- First submitted
- 16 Oct 2009
- Last updated
- 19 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00997464
- Acronym / sponsor ID
- CCR3200
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom
- Study start
- Aug 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 19 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Men with strong family history of prostate cancer.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale)
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Rosalind Eeles principal investigator
Institute of Cancer Research, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Rosalind Eeles (02086613642, rosalind.eeles@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether cancer worry changes between the two time-points (measured using the Impact of Event Scale). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2009.