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NCT01514669 Clinical Trial

Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer

Prostate Cancer Clinical Trial

Official title:
Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01514669
Other study ID # 133719
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 2012
Est. completion date February 2025

Study information
Verified date December 2023
Source University of Arkansas
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this research study is to compare profiles in the blood and tears of patients with and without prostate cancer with the goal of developing a method of separating men with aggressive and non-aggressive disease.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 35 Years to 85 Years
Eligibility Inclusion Criteria: 1. Male, 35-85 years old 2. Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.) 3. Patients who present for the evaluation of a palpable nodule or induration on prostate exam 4. Patients who meet the requirements of Group 1, 2, or 3 of the protocol Exclusion Criteria: 1. Patient < 35 or > 85 years of age 2. Concurrent eye infection or trauma, including active conjunctivitis 3. Abnormal production of tears (too much or too little) 4. Any other conditions the PI or staff feels will not fulfill the criteria for study entry or will place the subject in a harmful environment 5. Atypia on prostate biopsy report

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Arkansas for Medical Sciences Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
University of Arkansas

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tear Sample Tear sample will be taken at the initial clinic visit 1 day
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