Benign Disease, Breast Cancer, Colon Cancer, Ovarian Cancer
Conditions
Keywords
Screening tool for cancer
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.
Interventions
OTHERTear 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.
Sponsors
Tenenbaum Family Foundation
University of Arkansas
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed