ACT: Analyzing the Composition of Tears to Identify Cancer

Sponsor

University of Arkansas (Other)

Overall Status

Completed

CT.gov ID

NCT00574678

Collaborator

Tenenbaum Family Foundation (Other)

150

Enrollment

Location

Arm

110

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Ovarian Cancer Colon Cancer Benign Disease	Other: Tear collection	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Dec 1, 2006

Actual Primary Completion Date :

Feb 1, 2016

Actual Study Completion Date :

Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1	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. Other Names: SELDI-MS

Arm

Intervention/Treatment

No Intervention: 1

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.

Other Names:

SELDI-MS

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arkansas For Medical Sciences	Little Rock	Arkansas	United States	72205

Sponsors and Collaborators

University of Arkansas
Tenenbaum Family Foundation

Investigators

Principal Investigator: V. Suzanne Klimberg, MD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Arkansas

ClinicalTrials.gov Identifier:

NCT00574678

Other Study ID Numbers:

71853

First Posted:

Dec 17, 2007

Last Update Posted:

Aug 5, 2021

Last Verified:

Feb 1, 2016

Keywords provided by University of Arkansas

Screening tool for cancer

Study Results

No Results Posted as of Aug 5, 2021