Study of a Polymorphism in Patients With Prostate Cancer

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00900185
• Other study ID #: CDR0000304552
• Secondary ID: NCI-03-C-0153NU-
• Status: Completed
• Phase: N/A
• First received: May 9, 2009
• Last updated: April 29, 2015

Study information

• Verified date: February 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Genetic:
• mutation analysis

• polymerase chain reaction

• polymorphism analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

References & Publications (2)

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. Epub 2004 Dec 16. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants			No
Secondary	Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants			No