Analyzing the Composition of Tears to Identify Cancer - Full Text View

Sponsors and Collaborators:	University of Arkansas Tenenbaum Family Foundation Larry Suva, PhD.
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00574678

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Ovarian Cancer Colon Cancer Benign Disease	Other: Tear collection	Phase I Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	ACT: Analyzing the Composition of Tears to Identify Cancer (Breast, Ovarian, Colon)

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Ovarian Cancer

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	December 2006
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention	Other: Tear collection 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.

Arms

Assigned Interventions

1: No Intervention

Other: Tear collection

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574678

Contacts

Contact: Laura Adkins, MAP, CCRP	501-296-1501 ext 1123	lladkins@uams.edu
Contact: Maureen Smith, RNP	501-296-1505 ext 1115	smithmaureena@uams.edu

Locations

United States, Arkansas
University of Arkansas For Medical Sciences	Recruiting
Little Rock, Arkansas, United States, 72205
Principal Investigator: V. Suzanne Klimberg, MD

Sponsors and Collaborators

University of Arkansas

Tenenbaum Family Foundation

Larry Suva, PhD.

Investigators

Principal Investigator:

V. Suzanne Klimberg, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	University of Arkansas for Medical Sciences ( V. Suzanne Klimberg, MD )
Study ID Numbers:	UAMS 71853
Study First Received:	December 13, 2007
Last Updated:	July 13, 2009
ClinicalTrials.gov Identifier:	NCT00574678 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by University of Arkansas:

Screening tool for cancer

Study placed in the following topic categories:

Lacerations
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases

Intestinal Diseases
Intestinal Neoplasms
Genital Diseases, Female
Digestive System Diseases
Ovarian Cancer
Gastrointestinal Neoplasms
Endocrinopathy
Colonic Neoplasms
Breast Diseases
Colorectal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Gonadal Disorders
Gastrointestinal Diseases
Colonic Diseases
Genital Neoplasms, Female
Endocrine System Diseases
Breast Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Intestinal Diseases

Intestinal Neoplasms
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colonic Neoplasms
Breast Diseases
Colorectal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009