Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer

Study summary

Primary Objective: * To determine the clinical sensitivity and specificity of the Biomoda CyPath™ Early Lung Cancer Detection Assay using sputum specimens from two cohorts of participants and estimate the required sample size to finalize a protocol for a pivotal study. Secondary Objectives: * To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay in a clinical setting to identify cancer cells, as assessed by TCPP labeled cancer cells demonstrating red fluorescence under a microscope with ultraviolet (UV) light being observed with a FITC (Fluorescein isothiocyanate) Filter. * To assess the capability of the Biomoda CyPath™ Early Lung Cancer Detection Assay to detect pre-invasive cancer in comparison with PAP sputum cytology and routine CT scan.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedCyPath

The study team can explain what participation involves.

Who it may be forLung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 30, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Biomoda Inc.

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: Biomoda Inc.
Interventions being studied: Device: CyPath

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Male or female Veterans
Study Participants must be willing to provide primary care physician contact information and agree to have medical information released if indicated
Meet requirements of one of the two cohorts in the study:
Cohort 1: Heavy Smoker
Defined as 20 pack years or greater (e.g., 1 pack/day for 20 years or 2 packs/day for 10 years).
Cohort 2: Known Lung Cancer
Recently diagnosed with Stage I - IV lung cancer with either central (bronchogenic) or peripheral tumor location, and prior to surgery or other therapy for the cancer; Participants with a central or peripheral pulmonary recurrence of lung cancer following primary therapy may also be enrolled. Sputum samples for this cohort may be collected at or after a diagnostic bronchoscopy.

Reasons someone may not be able to joinExclusion criteria

Severe obstructive lung disease
Angina with minimal exertion
Pregnancy
Have or have had cancer other than lung cancer within one year
Worked in the mining Industry

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Waterbury Pulmonary ResearchWaterbury, Connecticut
Helen F. Graham Cancer Center, Christiana Care Health SystemNewark, Delaware
Radiology Associates of AlbuquerqueAlbuquerque, New Mexico

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 30, 2019. Always confirm current availability with the study team.

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