Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 24 for:    Porphyrins

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00894127
Recruitment Status : Completed
First Posted : May 6, 2009
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Collaborators:
Alquest
Quintiles, Inc.
Radiology Associates of Albuquerque
New Mexico Technical Institute of Mining and Technology
US Department of Veterans Affairs
Information provided by (Responsible Party):
Biomoda Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Condition Lung Cancer
Intervention Device: CyPath
Enrollment 128
Recruitment Details

Recruitment Period: March 2009 to February 2011

Helen F. Graham Cancer Center Newark, DE Christiana Care Health System, Newark, DE Waterbury Pulmonary Associates, Waterbury, CT

Pre-assignment Details  
Arm/Group Title Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Hide Arm/Group Description Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
Period Title: Overall Study
Started 128
Completed 128
Not Completed 0
Arm/Group Title Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Hide Arm/Group Description Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
Overall Number of Baseline Participants 128
Hide Baseline Analysis Population Description
Male and female subjects aged 18 years of age and older were recruited from the pool of United States’ military veterans who responded to public advertisements and recruitment pamphlets disseminated at veteran’s events,
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants
cohort 1 n=102 57.2  (11.6)
cohort 2 n=26 61.5  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants
Female
17
  13.3%
Male
111
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 128 participants
128
1.Primary Outcome
Title 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.
Hide Description

Various measurements were taken to report the validity of the findings. Sensitivity in this study was defined as the percentage of tumor cells that were positively identified. Specificity was the percentage of true positive signals and accuracy calculated as the percentage of those patients identified as having cancer.

Testing for the study was performed at multiple locations to assess the efficacy of the CyPath Assay to detect lung cancer cells exfoliated from lung tumors present in deep-lung sputum. Participants who satisfied the inclusion/exclusion criteria were enrolled in the study and assigned to one of two cohorts (smoker with clear Low dose CT scan or "high-risk" normals," and lung cancer confirmed by pathology or "cancer").

Time Frame March 2011
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Hide Arm/Group Description:

Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.

CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum

Overall Number of Participants Analyzed 128
Measure Type: Number
Unit of Measure: percentage
Sensitivity 77
Specificity 58
Accuracy 81.3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Hide Arm/Group Description

Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.

CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum

All-Cause Mortality
Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Affected / at Risk (%)
Total   0/128 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Single Arm Labeling of Deep-Lung Sputum Samples With TCPP
Affected / at Risk (%)
Total   0/128 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Zannes
Organization: bioAffinity
Phone: 505-400-9747
Responsible Party: Biomoda Inc.
ClinicalTrials.gov Identifier: NCT00894127     History of Changes
Other Study ID Numbers: MODA-001
First Submitted: May 4, 2009
First Posted: May 6, 2009
Results First Submitted: August 19, 2014
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014