Breast Cancer, Melanoma, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer
Conditions
Keywords
Preventative Screening, Protein Biomarkers, Lacrimal Tear Fluid, Non-invasive, Tear Collection, CLIA Laboratory, Affordable, Proteomics, Metabolomics, Protein Microarray, ELISA assay
Brief summary
This Pilot Study is to investigate the tear proteins in a multitude of cancer types and indulge in biomarker discovery to manufacture simple, accurate, and novel tear-based diagnostic tests.
Detailed description
The Pilot Study is an observational study to investigate the diagnostic potential of tear proteins for Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon cancer. In this pilot study, we use lacrimal gland fluid (tears) as a liquid biopsy source for investigating the protein repertoire and conducting biomarker discovery studies with a goal to develop new tear-based tests that can detect crucial cancer-related biomarkers in the pan-cancer types. Proteomic studies on tears have shown to express between 500-1500 proteins with \ 35% overlap with serum proteome. The easy accessibility of tear fluid with minimal post-processing procedures and better access to lower molecular weight proteins make tears an ideal source to identify commonly associated cancer biomarkers. Additionally, the results from this study will aid in improving our understanding of the cancer types and commonalities that exist between them.
Interventions
OTHERSchirmer strip, a Class I Medical Device typically used to test for dry eye.
Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.
Sponsors
Arkansas Urology
CARTI
Namida Lab
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* 18-100 years of age * Presenting for the evaluation of an abnormal exam or test (mammogram, ultrasound, MRI, PET, etc.) * Presenting for the evaluation of a palpable lump or mass * Presenting with a mass may be pre or post-biopsy/diagnostic as long as there is a portion of the mass remaining. * Have been diagnosed but have not received treatment
Exclusion criteria
* Less than 18 years of age OR more than 100 years of age * Concurrent eye infection or trauma * Acute conjunctivitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify Cancer-related Biomarkers | Dec 2023 | A tear protein repertoire will be created to identify key cancer biomarkers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Protein Concentrations | Dec 2023 | The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles. |
Countries
United States
Outcome results
None listed