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NCT05223218 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05223218
Other study ID # IRB#56402
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date August 25, 2021
Est. completion date December 2023

Study information
Verified date June 2023
Source Namida Lab
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 2023
Est. primary completion date November 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 100 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Namida Lab Fayetteville Arkansas

Sponsors (3)
Lead Sponsor Collaborator
Namida Lab Arkansas Urology, CARTI

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identify Cancer-related Biomarkers A tear protein repertoire will be created to identify key cancer biomarkers Dec 2023
Secondary Tear Protein Concentrations The total protein concentrations will be measured at different temperature conditions to determine the protein degradation profiles. Dec 2023
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