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

June 29, 2023 updated by: Namida Lab

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

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

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • Namida Lab

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population presented in the inclusion criteria will be recruited at multiple cancer centers and clinical sites.

Description

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

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 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.
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 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.
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 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.
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 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.
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 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.
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 test for dry eye.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify Cancer-related Biomarkers
Time Frame: Dec 2023
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
Time Frame: Dec 2023
The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles.
Dec 2023

Collaborators and Investigators

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

Sponsor

Namida Lab

Collaborators

Arkansas Urology
CARTI

Investigators

  • Principal Investigator: Prashanth Ravishankar, PhD, Namida Lab Inc

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 Major Dates

Study Start (Actual)

August 25, 2021

Primary Completion (Estimated)

November 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

February 3, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#56402

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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