Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
|ClinicalTrials.gov Identifier: NCT00373035|
Recruitment Status : Completed
First Posted : September 7, 2006
Last Update Posted : January 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Prostate Cancer||Genetic: proteomic profiling Other: immunological diagnostic method Other: laboratory biomarker analysis Other: mass spectrometry Procedure: biopsy Procedure: ultrasound imaging|
- 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).
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Biomarkers of Prostate Cancer|
|Study Start Date :||February 2006|
|Primary Completion Date :||July 2006|
- Unique proteins or peptides associated with prostate cancer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373035
|United States, California|
|Menlo Park, California, United States, 94025|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157|
|Study Chair:||Frank M. Torti, MD, MPH||Wake Forest University Health Sciences|