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

December 4, 2023 updated by: University of Arkansas
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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from those outpatients followed in the Winthrop P. Rockefeller Cancer Institute (located at the University of Arkansas for Medical Sciences).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
No treatment
No Tx, this is observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear Sample
Time Frame: 1 day
Tear sample will be taken at the initial clinic visit
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 17, 2012

First Submitted That Met QC Criteria

January 17, 2012

First Posted (Estimated)

January 23, 2012

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133719

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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