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

NCT ID: NCT01514669

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-01

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No treatment

No Tx, this is observational

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan Diekman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

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University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

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United States

Other Identifiers

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133719

Identifier Type: -

Identifier Source: org_study_id

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