DNA Changes in Patients With Prostate Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Genetic: polymorphism analysis Other: laboratory biomarker analysis |
| Study Type: | Observational |
| Official Title: | Assessment of SNP Genotypes in Men With Prostate Cancer |
- Frequency of single nucleotide polymorphism (SNP) genotypes [ Designated as safety issue: No ]
- Age of onset of prostate cancer in patients and their affected siblings [ Designated as safety issue: No ]
- Likelihood that given SNPs result in disease as assessed by Mendelian genetics [ Designated as safety issue: No ]
- Odds ratio of developing prostate cancer in the presence of SNPs [ Designated as safety issue: No ]
- Correlation of SNP genotypes of patients enrolled in ECOG-E3805 with disease progression [ Designated as safety issue: No ]
| Estimated Enrollment: | 646 |
| Study Start Date: | July 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00899184 History of Changes |
| Other Study ID Numbers: | CDR0000492784, ECOG-E1Y97T1, ECOG-O00PCONS01 |
| Study First Received: | May 9, 2009 |
| Last Updated: | February 18, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent prostate cancer stage IV prostate cancer stage I prostate cancer |
stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |
ClinicalTrials.gov processed this record on June 13, 2013