Investigating The Diagnostic Potential Of Tear Proteins In Cancer - A Pilot Study

Study Overview

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

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.

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.

Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Prostate Cancer
Melanoma

OTHER: Schirmer strip, a Class I Medical Device typically used to test for dry eye.

IRB#56402

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-01-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-06-29
First Submitted that Met QC Criteria 2022-01-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-03
First Posted (ACTUAL) 2022-02-03	Results First Posted N/A	Last Verified 2023-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: 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	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.
: 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	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.
: 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	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.
: 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	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.
: 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	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.
: 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 te	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.

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

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

Less than 18 years of age OR more than 100 years of age
Concurrent eye infection or trauma
Acute conjunctivitis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Arkansas Urology
CARTI

Investigators

PRINCIPAL_INVESTIGATOR: Prashanth Ravishankar, PhD, Namida Lab Inc

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record