Study of a Polymorphism in Patients With Prostate Cancer

April 29, 2015 updated by: National Cancer Institute (NCI)

Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer

RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA.

PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer.

Secondary

  • Determine the incidence of this polymorphism in African-American patients with prostate cancer.

OUTLINE: This is a retrospective, multicenter study.

DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern.

PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.

Study Type

Observational

Enrollment (Anticipated)

750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of prostate cancer OR healthy participant

  • Patient enrolled on an IRB-approved clinical trial at the National Cancer Institute or Northwestern University, including, but not limited to, any of the following:

    • NCI-99-C-0052
    • NCI-95-C-0178
    • NCI-00-C-003
    • NCI-00-C-0080

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants

Secondary Outcome Measures

Outcome Measure
Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Study Chair: William D. Figg, PharmD, National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria

May 9, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 29, 2015

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000304552
  • NCI-03-C-0153
  • NU-98U2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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