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Study of a Polymorphism in Patients With Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
mutation analysis
polymerase chain reaction
polymorphism analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 9, 2009
    Last Updated
    April 29, 2015
    Sponsor
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00900185
    Brief Title
    Study of a Polymorphism in Patients With Prostate Cancer
    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
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

    7. Study Design

    Enrollment
    750 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Genetic
    Intervention Name(s)
    mutation analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    polymerase chain reaction
    Intervention Type
    Genetic
    Intervention Name(s)
    polymorphism analysis
    Primary Outcome Measure Information:
    Title
    Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants
    Secondary Outcome Measure Information:
    Title
    Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants

    10. Eligibility

    Sex
    Male
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    William D. Figg, PharmD
    Organizational Affiliation
    National Cancer Institute (NCI)
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    15662127
    Citation
    Macpherson GR, Singh AS, Bennett CL, Venzon DJ, Liewehr DJ, Franks ME, Dahut WL, Kantoff PW, Price DK, Figg WD. Genotyping and functional analysis of the D104N variant of human endostatin. Cancer Biol Ther. 2004 Dec;3(12):1298-303. doi: 10.4161/cbt.3.12.1453. Epub 2004 Dec 16.
    Results Reference
    result
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

    Study of a Polymorphism in Patients With Prostate Cancer

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