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Analyzing the Composition of Tears to Identify Cancer (ACT)

University of Arkansas logo

University of Arkansas

Status and phase

Completed
Phase 2
Phase 1

Conditions

Benign Disease
Breast Cancer
Colon Cancer
Ovarian Cancer

Treatments

Other: Tear collection

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No 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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

1
No Intervention group
Treatment:
Other: Tear collection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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