Analyzing the Composition of Tears to Identify Cancer

Phase 1

Completed

• Conditions: Ovarian Cancer; Benign Disease; Breast Cancer; Colon Cancer
• Interventions: Other: Tear collection

• Registration Number: NCT00574678
• Lead Sponsor: University of Arkansas

Brief Summary

This study will further evaluate the use of protein identification or protein pattern (signature) found in tears. We hypothesize that differences exist between the protein profile in tear fluid from patients with versus without cancer.

Detailed Description

Specifically, this study will compare the protein profile in tear fluid from patients with breast, ovarian or colon cancer versus "normal male and female patients" for differences that show promise as a diagnostic indicator. If such differences can be found, then their diagnostic potential will be assessed and developed further in a subsequent study. The long-term goal of this project will be to develop a screening tool for the detection of breast and/or other cancers.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2007-12-13
• Study First Submitted QC: 2007-12-13
• Study First Posted: 2007-12-17
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2021-08-04
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Female or male, 18-100 years old
• Patients who present for a routine check-up
• Patients who present for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.)
• May or may not have a mass present
• Patients who present for the evaluation of a palpable lump or mass
• Patients may be pre or post biopsy for a mass, as long as there is a portion of the mass remaining

Exclusion Criteria

• Patient < 18 y/o or > 100 y/o
• Concurrent eye infection or trauma
• Active conjunctivitis
• Abnormal production of tears (too much or too little)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Tear collection	-

Primary Outcome Measures

Name	Time	Method
This study will further evaluate the use of tumor markers (substances in body fluids that may be elevated as a consequence of certain diseases or conditions) in the diagnosis of breast and/or other cancers.	Collection of specimen and analysis with SELDI-MS

Trial Locations

Locations (1)

University of Arkansas For Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States