Prostate CancerNCT00523471
Blood Test to Measure DNA Damage in Blood
An observational study of Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
To check the radiosensitivity level in individual patients based on their DNA damage level. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2007to Jun 2010
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: community sample
Who may be able to join
- prostate cancer diagnosis
- undergoing radiotherapy
- agree to participate in study
Who cannot join
- not willing to participate
- not undergoing radiotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gamma-H2AX as a Molecular Predictor of Prostate Cancer Radiosensitivity
To check the radiosensitivity level in individual patients based on their DNA damage level.
- Conditions
- Prostate Cancer
- Being tested
- Blood test
- Keywords
- prostate cancer, gamma H2AX, radiosensitivity
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2010
- Study completionJun 2010
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.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadeem Pervez, MBBS, FRCPC, Principal investigator, AHS Cancer Control Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523471
- Sponsor's protocol ID
- GU-6-0076/ethics 23586
- Status last verified
- Apr 2012
- First submitted
- 30 Aug 2007
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gamma-H2AX as a Molecular Predictor of Prostate Cancer Radiosensitivity
- ClinicalTrials.gov ID
- NCT00523471
- Acronym / sponsor ID
- GU-6-0076/ethics 23586
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, gamma H2AX, radiosensitivity
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Aug 2007 (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.
To check the radiosensitivity level in individual patients based on their DNA damage level.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- community sample
Key inclusion criteria (3 listed)
- prostate cancer diagnosis
- undergoing radiotherapy
- agree to participate in study
Key exclusion criteria (2 listed)
- not willing to participate
- not undergoing radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
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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.
Nadeem Pervez, MBBS, FRCPC principal investigator
AHS Cancer Control Alberta
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 AHS Cancer Control Alberta at 1 site in Canada.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 26 Feb 2016. 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 Canada. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 26 Feb 2016.