Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
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.
Checked against the public recordLast updated Oct 30, 2019 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Diagnostic
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Biomoda Inc.
- Interventions being studied
- Device: CyPath
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion 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. Exclusion 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.
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.