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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Ovarian Cancer, Colon Cancer, Benign Disease

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Trial Information

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

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.

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

Collection of specimen and analysis with SELDI-MS

Safety Issue:


Principal Investigator

V. Suzanne Klimberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Food and Drug Administration

Study ID:

UAMS 71853



Start Date:

December 2006

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Benign Disease
  • Screening tool for cancer
  • Breast Neoplasms
  • Colonic Neoplasms
  • Ovarian Neoplasms



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205