Analyzing the Composition of Tears to Identify Cancer

Breast Cancer Clinical Trial

— ACT  

Official title:

ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574678
• Other study ID #: 71853
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2006
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Benign Disease
• Breast Cancer
• Colon Cancer
• Ovarian Cancer

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Tenenbaum Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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