Analyzing the Composition of Tears to Identify Cancer

NCT00574678 | Completed Phase 1

• 1 other identifier: 71853
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ovarian Cancer; Colon Cancer; Benign Disease

Keywords

Screening tool for cancer

Outcome Measures

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.

  Collection of specimen and analysis with SELDI-MS

Study Arms (1)

1

NO INTERVENTION

Other: Tear collection

Interventions

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.

Also known as: SELDI-MS

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient \< 18 y/o or \> 100 y/o
• Concurrent eye infection or trauma
• Active conjunctivitis
• Abnormal production of tears (too much or too little)

Sponsors & Collaborators

• University of Arkansas: lead
• Tenenbaum Family Foundation: collaborator

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Colonic Neoplasms

Interventions

Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mass Spectrometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• V. Suzanne Klimberg, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: December 1, 2006
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: August 5, 2021

Record last verified: 2016-02

Locations

US (1)