Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00373035
First received: September 6, 2006
Last updated: June 4, 2013
Last verified: June 2013

September 6, 2006
June 4, 2013
February 2006
July 2006   (final data collection date for primary outcome measure)
Unique proteins or peptides associated with prostate cancer [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00373035 on ClinicalTrials.gov Archive Site
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Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
Biomarkers of Prostate Cancer

RATIONALE: Collecting and storing samples of blood and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.

OBJECTIVES:

Primary

  • Identify unique proteins or peptides that are associated with prostate cancer by comparing the proteomic or metabolomic analysis of serum, plasma, and urine from patients with histological evidence of prostate cancer to those without prostate cancer (after transrectal ultrasound prostatic biopsy).

Secondary

  • Collect seminal fluid from a subset of patients to test the hypothesis that the fluid collected from the "target organ of injury" in prostate cancer will have a higher signal of proteins/peptides that are different from those without cancer and may help guide the identification of these differences in the serum, plasma, and urine.

OUTLINE: This is a pilot study.

Patients undergo collection of serum, plasma, and urine for biomarker/laboratory analysis. Samples are examined by proteomic/metabolomic analysis (by mass spectrometry) and immunoassays. Patients then undergo a transrectal ultrasonography prostatic biopsy.

PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

Observational
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Prostate Cancer
  • Genetic: proteomic profiling
  • Other: immunological diagnostic method
  • Other: laboratory biomarker analysis
  • Other: mass spectrometry
  • Procedure: biopsy
  • Procedure: ultrasound imaging
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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July 2006   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Indication for a transrectal ultrasonography prostatic biopsy (as part of normal patient care) due to elevated prostate-specific antigen, or abnormal digital rectal examination, or surveillance for prostate cancer

PATIENT CHARACTERISTICS:

  • No prior or other concurrent malignancy except for curatively treated basal cell carcinoma of the skin
  • No serious medical or psychiatric illness that would preclude informed consent
  • No concurrent acute illness

PRIOR CONCURRENT THERAPY:

  • No participation in another clinical trial within the past 30 days
  • No more than one enrollment into this study
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00373035
CCCWFU-85A03, CDR0000490117, CCCWFU-BG03-628
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Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Frank M. Torti, MD, MPH Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP