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:

National Cancer Institute (NCI)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

May 9, 2009

Last Updated Date

February 18, 2011

Start Date ^ICMJE

July 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00899184 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

DNA Changes in Patients With Prostate Cancer

Official Title ^ICMJE

Assessment of SNP Genotypes in Men With Prostate Cancer

Brief 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.

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Not Provided

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition ^ICMJE

Prostate Cancer

Intervention ^ICMJE

Genetic: polymorphism analysis
Other: laboratory biomarker analysis

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

646

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00899184

Other Study ID Numbers ^ICMJE

CDR0000492784, ECOG-E1Y97T1, ECOG-O00PCONS01

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Eastern Cooperative Oncology Group

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Kim M. Hirshfield, MD, PhD

Cancer Institute of New Jersey

Information Provided By

National Cancer Institute (NCI)

Verification Date

January 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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