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

Sponsor
University of Arkansas (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01514669
Collaborator
(none)
75
Enrollment
1
Location
133
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Analyzing the Composition of Tears and Blood for Discovery of Novel Signatures of Aggressive Prostate Cancer
    Study Start Date :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    No treatment

    No Tx, this is observational

    Outcome Measures

    Primary Outcome Measures

    1. Tear Sample [1 day]

      Tear sample will be taken at the initial clinic visit

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 85 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205

    Sponsors and Collaborators

    • University of Arkansas

    Investigators

    • Principal Investigator: Alan Diekman, Ph.D., University of Arkansas

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Arkansas
    ClinicalTrials.gov Identifier:
    NCT01514669
    Other Study ID Numbers:
    • 133719
    First Posted:
    Jan 23, 2012
    Last Update Posted:
    Mar 2, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Prostatic Neoplasms

    Study Results

    No Results Posted as of Mar 2, 2022