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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01514669
Recruitment Status : Active, not recruiting
First Posted : January 23, 2012
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):

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
Prostate Cancer

Study Design

Study Type : Observational
Estimated 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 : January 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
No treatment


Outcome Measures

Primary Outcome Measures :
  1. Tear Sample [ Time Frame: 1 day ]
    Tear sample will be taken at the initial clinic visit


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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Senior)
Sexes 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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514669


Locations
United States, Arkansas
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
More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01514669     History of Changes
Other Study ID Numbers: 133719
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases