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

Completed · Phase 1/Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00894127

Run by

Biomoda Inc.

People needed

128

Starts

2009-03-01

Expected to finish

2011-03-01

Last updated by the study team

2019-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Waterbury Pulmonary Research — Waterbury, Connecticut, United States
• Helen F. Graham Cancer Center, Christiana Care Health System — Newark, Delaware, United States
• Radiology Associates of Albuquerque — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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