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Study of a Polymorphism in Patients With Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00900185
First received: May 9, 2009
Last updated: February 18, 2011
Last verified: February 2007
History of Changes
  Purpose

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.


Condition Intervention
Prostate Cancer
 Genetic: mutation analysis
Genetic: polymerase chain reaction
Genetic: polymorphism analysis

Study Type: Observational
Official Title: Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants [ Designated as safety issue: No ]

Estimated Enrollment: 750
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900185

Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Study Chair: William D. Figg, PharmD National Cancer Institute (NCI)
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Price DK, Macpherson GR, Dahut W, et al.: A mutation in COL18A1 and the association with prostate cancer. [Abstract] American Association for Cancer Research: 94th Annual Meeting, 11-14th July 2003, Washington, D.C. 44: A-4054, 810, 2003.

ClinicalTrials.gov Identifier: NCT00900185     History of Changes
Other Study ID Numbers: CDR0000304552, NCI-03-C-0153, NU-98U2
Study First Received: May 9, 2009
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage I prostate cancer
stage IIB prostate cancer
 stage IIA prostate cancer
stage III prostate cancer
stage IV 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 May 23, 2013