DNA Changes in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Assessment of SNP Genotypes in Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00899184
• Other study ID #: CDR0000492784
• Secondary ID: ECOG-E1Y97T1ECOG
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: May 17, 2017
• Start date: May 23, 2006
• Est. completion date: May 30, 2007

Study information

• Verified date: May 2017
• Source: Eastern Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

PURPOSE: This laboratory study is looking at changes in DNA in patients and their brothers with prostate cancer.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 646
• Est. completion date: May 30, 2007
• Est. primary completion date: May 30, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
ECOG-ACRIN Cancer Research Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of single nucleotide polymorphism (SNP) genotypes		1 month
Primary	Age of onset of prostate cancer in patients and their affected siblings		1 month