Biomarkers in Patients Undergoing Transrectal Ultrasound Prostate Biopsy
NCT ID: NCT00373035
Last Updated: 2017-01-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2006-02-28
Brief Summary
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PURPOSE: This laboratory study is looking at biomarkers in patients undergoing transrectal ultrasound prostate biopsy.
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Detailed Description
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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.
Conditions
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Interventions
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proteomic profiling
immunological diagnostic method
laboratory biomarker analysis
mass spectrometry
biopsy
ultrasound imaging
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Frank M. Torti, MD, MPH
Role: STUDY_CHAIR
Wake Forest University Health Sciences
Locations
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SurroMed Incorporated
Menlo Park, California, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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CDR0000490117
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU-BG03-628
Identifier Type: -
Identifier Source: secondary_id
CCCWFU-85A03
Identifier Type: -
Identifier Source: org_study_id
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