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Analyzing the Composition of Tears to Identify Cancer (ACT)

This study has been completed.
Tenenbaum Family Foundation
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: December 13, 2007
Last updated: February 2, 2016
Last verified: February 2016
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 Intervention Phase
Breast Cancer
Ovarian Cancer
Colon Cancer
Benign Disease
Other: Tear collection
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

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. [ Time Frame: Collection of specimen and analysis with SELDI-MS ]

Enrollment: 150
Study Start Date: December 2006
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: SELDI-MS

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00574678

United States, Arkansas
University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Tenenbaum Family Foundation
Principal Investigator: V. Suzanne Klimberg, MD University of Arkansas
  More Information

Responsible Party: University of Arkansas Identifier: NCT00574678     History of Changes
Other Study ID Numbers: UAMS 71853
Study First Received: December 13, 2007
Last Updated: February 2, 2016

Keywords provided by University of Arkansas:
Screening tool for cancer processed this record on April 28, 2017