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

NCT05223218 | Unknown

• 1 other identifier: IRB#56402
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ovarian Cancer; Pancreatic Cancer; Prostate Cancer; Melanoma

Keywords

Preventative Screening; Protein Biomarkers; Lacrimal Tear Fluid; Non-invasive; Tear Collection; CLIA Laboratory; Affordable; Proteomics; Metabolomics; Protein Microarray; ELISA assay

Outcome Measures

Primary Outcomes (1)

• Identify Cancer-related Biomarkers

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

  Dec 2023

Secondary Outcomes (1)

• Tear Protein Concentrations

  Dec 2023

Study Arms (6)

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.

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.

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.

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.

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.

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.

Interventions

Schirmer strip, a Class I Medical Device typically used to test for dry eye. OTHER

Schirmer strip is a Class I Medical Device typically used to test for dry eye and will be used to collect lacrimal tear fluids.

Breast Cancer; Colon Cancer; Healthy Control; Melanoma; Pancreatic Cancer; Prostate Cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Less than 18 years of age OR more than 100 years of age
• Concurrent eye infection or trauma
• Acute conjunctivitis

Sponsors & Collaborators

• Namida Lab: lead
• Arkansas Urology: collaborator
• CARTI: collaborator

Study Sites (1)

Namida Lab

Fayetteville, Arkansas, 72703, United States

Location

Biospecimen

Lacrimal tear fluids will be stored for conducting pr

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms; Prostatic Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Prashanth Ravishankar, PhD

  Namida Lab Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: February 3, 2022
• Study Start: August 25, 2021
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

US (1)