Combination of Serum Measurements of Molecular Biomarkers and Serum Protein Profiling Can be Used to Predict Which Patients Undergoing Prostatic Biopsy Will be Diagnosed With Cancer
NCT00773773 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58
Last updated 2024-09-04
Summary
This is a prospective, serum proteomics study of men who are to undergo prostate biopsy. The purpose is to determine if proteomic profiles can be used to distinguish between men with prostate cancer on biopsy from men with no cancer on biopsy.
Conditions
- Prostate Cancer
- Elevated Prostate Specific Antigen (PSA)
Interventions
- OTHER
-
serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Patients referred for prostate biopsy as part of their routine care are to be recruited. Patients will undergo standard medical evaluation/care by undergoing a prostate biopsy because of an elevated PSA blood test and/or an abnormal digital rectal prostate examination. The protocol involves obtaining the research blood sample at the time of routine pre-biopsy blood draw. As such, an extra five (40 mL) tubes of blood will be drawn. The serum specimens obtained will be utilized for proteomic profiling comprising MALDI-TOF MS, and serum biomarker assays.
Sponsors & Collaborators
-
National Institutes of Health (NIH)
collaborator NIH -
New York Presbyterian Hospital
collaborator OTHER -
Weill Medical College of Cornell University
collaborator OTHER -
State University of New York - Downstate Medical Center
collaborator OTHER - collaborator OTHER
-
Kings County Hospital Department of Emergency Medicine
collaborator OTHER -
Memorial Sloan Kettering Cancer Center
lead OTHER
Principal Investigators
-
Paul Tempst, PhD · Memorial Sloan Kettering Cancer Center
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-10-14
- Primary Completion
- 2024-03-08
- Completion
- 2024-03-08
Countries
- United States
Study Locations
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