Status:
COMPLETED
Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
Lead Sponsor:
Biomoda Inc.
Collaborating Sponsors:
Alquest
Quintiles, Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 estimat...
Detailed Description
Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) is a porphyrin that can label cancer cells by reacting to the increased number of low-density lipoproteins coating the surface of cancer cells and the poro...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00894127
Start Date
March 1 2009
End Date
March 1 2011
Last Update
October 30 2019
Active Locations (3)
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1
Waterbury Pulmonary Research
Waterbury, Connecticut, United States, 06708
2
Helen F. Graham Cancer Center, Christiana Care Health System
Newark, Delaware, United States, 19713
3
Radiology Associates of Albuquerque
Albuquerque, New Mexico, United States, 87109