DNA Changes in Patients With Prostate Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00899184
First received: May 9, 2009
Last updated: February 18, 2011
Last verified: January 2007
  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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899184

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Kim M. Hirshfield, MD, PhD Rutgers Cancer Institute of New Jersey
  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 April 17, 2014