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

• Conditions: Breast Cancer; Prostate Cancer; Pancreatic Cancer; Melanoma; Ovarian Cancer

• Registration Number: NCT05223218
• Lead Sponsor: Namida Lab

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.

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-03
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-29
• Last Update Posted: 2023-07-03
• Primary Completion: 2023-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Tear Protein Concentrations	Dec 2023	The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles.

Trial Locations

Locations (1)

Namida Lab; 🇺🇸 Fayetteville, Arkansas, United States