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Clinical Trials/NCT00574678
NCT00574678
Completed
Phase 1

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

University of Arkansas1 site in 1 country150 target enrollmentDecember 2006

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Arkansas
Enrollment
150
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2006
End Date
February 2016
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

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

Study Sites (1)

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