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

Study results available
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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

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
  • NYU Langone Health

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00773773 on ClinicalTrials.gov