Analyzing the Composition of Tears to Identify Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Ovarian Cancer, Colon Cancer, Benign Disease

Intervention / Treatment
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* Other: Tear collection


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | Other: Tear collection<br>* 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.<br>* Other names: SELDI-MS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening tool for cancer