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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: January 17, 2012
Last updated: February 25, 2016
Last verified: February 2016
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.

Prostate Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Tear Sample [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Tear sample will be taken at the initial clinic visit

Biospecimen Retention:   Samples With DNA
Tear Sample collection; serum sample collection

Estimated Enrollment: 75
Study Start Date: January 2012
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
No treatment


Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Male
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).

Inclusion Criteria:

  1. Male, 35-80 years old
  2. Patients who present for a routine check-up
  3. Patients who present for the evaluation of an abnormal exam or test (elevated PSA, abnormal DRE, etc.)
  4. Patients who present for the evaluation of a palpable nodule or induration on prostate exam
  5. Patients may present with a biopsy proven prostate cancer from outside physician for inclusion into arms 2 or 3
  6. For group 1 a negative prostate biopsy

Exclusion Criteria:

  1. Patient < 35 or > 81 years of age
  2. Concurrent eye infection or trauma
  3. Active conjunctivitis
  4. Abnormal production of tears (too much or too little)
  5. 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
  6. Atypia on prostate biopsy report
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01514669

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Alan Diekman, Ph.D. University of Arkansas
  More Information

Responsible Party: University of Arkansas Identifier: NCT01514669     History of Changes
Other Study ID Numbers: 133719 
Study First Received: January 17, 2012
Last Updated: February 25, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on May 30, 2016