Prostate CancerNCT00899184
DNA Changes in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by ECOG-ACRIN Cancer Research Group.
Trial summary
RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- polymorphism analysis and laboratory biomarker analysis
- How many people
- 646 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2006to 30 May 2007
- 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 18 to 120 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Meets one of the following criteria:
- Patient or sibling diagnosed with prostate cancer
- Cancer-free participant (healthy control)
- Whole blood sample available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Assessment of SNP Genotypes in Men With Prostate Cancer
RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.
Read the detailed description
OBJECTIVES:
- Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
- Determine the age of onset of prostate cancer in affected probands and affected siblings.
- Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
- Determine the odds ratio of developing prostate cancer in the presence of SNPs.
- Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.
Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.
PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- polymorphism analysis, laboratory biomarker analysis
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polymorphism analysisGenetic
laboratory biomarker analysisOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of single nucleotide polymorphism (SNP) genotypes
Measured: 1 month
Age of onset of prostate cancer in patients and their affected siblings
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study start23 May 2006
- Primary completion30 May 2007
- Study completion30 May 2007
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 ECOG-ACRIN Cancer Research GroupThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 646 participants (actual)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kim M. Hirshfield, MD, PhD, Study chair, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899184
- Sponsor's protocol ID
- CDR0000492784
- Other IDs
- ECOG-E1Y97T1, ECOG-O00PCONS01
- Status last verified
- May 2017
- First submitted
- 9 May 2009
- Last updated
- 19 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of SNP Genotypes in Men With Prostate Cancer
- ClinicalTrials.gov ID
- NCT00899184
- Acronym / sponsor ID
- CDR0000492784
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage IV prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 May 2006 (actual)
- Primary completion
- 30 May 2007 (actual)
- Study completion
- 30 May 2007 (actual)
- First posted
- 12 May 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.
RATIONALE: Collecting and storing samples of blood from patients and their brothers with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.
Detailed description
OBJECTIVES:
- Determine the frequency of single nucleotide polymorphism (SNP) genotypes in patients with prostate cancer, their affected siblings, and an unaffected healthy population (control).
- Determine the age of onset of prostate cancer in affected probands and affected siblings.
- Determine the penetrance or likelihood that given SNPs will result in disease in affected siblings based upon Mendelian genetics.
- Determine the odds ratio of developing prostate cancer in the presence of SNPs.
- Determine SNP genotypes in patients enrolled on ECOG-E3805, a prostate phase III study enrolling men with D2 prostate cancer treated with androgen-ablation therapy alone or androgen-ablation therapy with chemotherapy, and correlate them with disease progression (i.e., androgen independence).
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to ethnicity, age at diagnosis, and Gleason score.
Patients, their affected siblings, and healthy participants (controls) undergo collection of blood samples. Genomic DNA is extracted from whole blood and sequenced for single nucleotide polymorphisms (SNPs) in Akt and mdm-2 genes. SNP data is correlated with clinical and biographical data.
PROJECTED ACCRUAL: A total of 500 patients (250 probands and 250 siblings) and 146 healthy participants (controls) will be accrued for this study.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
Primary outcome
Frequency of single nucleotide polymorphism (SNP) genotypes
Time frame: 1 month
Age of onset of prostate cancer in patients and their affected siblings
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
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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.
Kim M. Hirshfield, MD, PhD study chair
Rutgers Cancer Institute of New Jersey
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by ECOG-ACRIN Cancer Research Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Frequency of single nucleotide polymorphism (SNP) genotypes (time frame: 1 month). The study lists 2 primary outcomes in all. 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 May 2017.