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Clinical Trials/NCT05223218
NCT05223218
Enrolling By Invitation
Not Applicable

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

Namida Lab1 site in 1 country500 target enrollmentAugust 25, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Namida Lab
Enrollment
500
Locations
1
Primary Endpoint
Identify Cancer-related Biomarkers
Status
Enrolling By Invitation
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 25, 2021
End Date
December 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Namida Lab
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Identify Cancer-related Biomarkers

Time Frame: Dec 2023

A tear protein repertoire will be created to identify key cancer biomarkers

Secondary Outcomes

  • Tear Protein Concentrations(Dec 2023)

Study Sites (1)

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