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Completed

NCT Number: NCT00574678

Analyzing the Composition of Tears to Identify Cancer

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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Benign Disease Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tear collection

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • Tenenbaum Family Foundation

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2007
Registry last updated
Aug 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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