NCT Number: NCT00899184
DNA Changes in Patients 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.
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Notify MeKey information
Conditions
Age range
18 year–120 year
Sex eligibility
Male
Study type
Observational
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
laboratory biomarker analysis
OtherPrimary outcomes
-
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
Sponsors and collaborators
Lead sponsor
ECOG-ACRIN Cancer Research Group
Network
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Assessment of SNP Genotypes in Men With Prostate Cancer
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- May 12, 2009
- Registry last updated
- May 19, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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