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
• Status: Enrolling by invitation
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Melanoma
• Ovarian Cancer
• Pancreatic Cancer
• Prostate Cancer

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