Investigating the Diagnostic Potential of Tear Proteins in Cancer - A Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigating the Diagnostic Potential of Tear Proteins in Breast, Ovarian, Prostate, Melanoma, Pancreatic, and Colon Cancer

Conditions
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Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Melanoma

Intervention / Treatment
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* Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast Cancer<br>Individuals aged between 18-100 years who are presenting for an 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 pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|
| Pancreatic Cancer<br>Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|
| Colon Cancer<br>Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|
| Prostate Cancer<br>Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|
| Melanoma<br>Individuals aged between 18-100 years who are presenting for an evaluation of an abnormal exam or test (Ultrasound, MRI, PET, etc.); presenting for the evaluation of a palpable lump or mass; presenting with a mass pre or post-biopsy as long as there is a portion of the mass remaining; or have been diagnosed with breast cancer but have not received treatment. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|
| Healthy Control<br>Individuals aged between 18-100 years who do not currently have a previous diagnosis of any cancer for which they are currently being treated. Lacrimal tear fluid samples are collected using a Schirmer strip, a Class I Medical Device typically used to test for dry eye. | Other: Schirmer strip, a Class I Medical Device typically used to test for dry eye.<br>* Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify Cancer-related Biomarkers | A tear protein repertoire will be created to identify key cancer biomarkers | Dec 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Protein Concentrations | The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles. | Dec 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Affordable, Preventative Screening, Protein Biomarkers, Lacrimal Tear Fluid, Non-invasive, Tear Collection, CLIA Laboratory, Proteomics, Metabolomics, Protein Microarray, ELISA assay