Analyzing the Composition of Tears to Identify Cancer

NCT ID: NCT00574678

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2016-02-29

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.

Conditions

Breast Cancer; Ovarian Cancer; Colon Cancer; Benign Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

Group Type: NO_INTERVENTION

Tear collection

Intervention Type: OTHER

A tear sample (\~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an "eye wash" method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed.

Interventions

Tear collection

A tear sample (\~75 microliters in a tuberculin syringe with the needle removed) will be taken at time of the initial clinic visit. After collection, the tears will be put directly on ice and taken to the lab. If it is not possible to obtain natural tears, an "eye wash" method using sterile saline will be employed and the fluid collected using the aforementioned technique. The SELDI-MS process will be conducted on the specimen immediately. The remainder of the tear specimen will be stored in a -80ºC freezer until completely analyzed.

Intervention Type: OTHER

Other Intervention Names

SELDI-MS

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tenenbaum Family Foundation

OTHER

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

V. Suzanne Klimberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

71853

Identifier Type: -

Identifier Source: org_study_id