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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Diseases, Male
Genital Neoplasms, Male
Neoplasms
 Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on February 26, 2015