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

Brief summary public domain (ClinicalTrials.gov)

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 public domain (ClinicalTrials.gov)

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.

Intervention public domain (ClinicalTrials.gov)

Other: Schirmer 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.

Arm public domain (ClinicalTrials.gov)

Breast Cancer (): 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.

Arm public domain (ClinicalTrials.gov)

Pancreatic Cancer (): 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.

Arm public domain (ClinicalTrials.gov)

Colon Cancer (): 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.

Arm public domain (ClinicalTrials.gov)

Prostate Cancer (): 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.

Arm public domain (ClinicalTrials.gov)

Melanoma (): 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.

Arm public domain (ClinicalTrials.gov)

Healthy Control (): 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.

Primary outcome public domain (ClinicalTrials.gov)

Identify Cancer-related Biomarkers. A tear protein repertoire will be created to identify key cancer biomarkers Time frame: Dec 2023.

Secondary outcome public domain (ClinicalTrials.gov)

Tear Protein Concentrations. Time frame: Dec 2023.

Eligibility public domain (ClinicalTrials.gov)

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

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 500 participants (estimated).