Lung Cancer
Conditions
Keywords
Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection
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 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.
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 porous nature of the cancer cell membrane, causing the cell to fluoresce under specific wavelengths of light. The primary objective of this clinical trial was to determine the clinical sensitivity and specificity of the CyPath® Lung Cancer Detection Assay (CyPath® Assay) using sputum specimens from two cohorts of Participants. The Study design included a protocol to assess the capability of the Biomoda CyPath® Lung Cancer Detection Assay to detect cancer in comparison with routine high-resolution, low-dose Computed Tomography (LDCT) scans. Optimization of the Assay can lead to improved sensitivity and specificity. Increase in sample size and evaluation of the entire sputum sample can increase data collection and differentiation between cohorts. Technicians in the current Study examined 12 slides containing approximately 600,000 cells. The average sputum sample pellet translates to a potential of approximately 3.5 million cells for evaluation. Evaluating the full sputum sample with the CyPath® Assay can be accomplished through flow cytometry and would increase the capture and analysis of exfoliated cancer cells in the sample. In-house studies evaluated samples from five different cancer cell lines using flow cytometry. Preliminary results showed that cancer cell lines were detected with significant fluorescence apart from normal cell fluorescence. Refinements for using the flow cytometer include optimizing the liquid-based assay and sample analysis and focus on concentration, incubation time and optimal sample volume.
Interventions
DEVICECyPath
CyPath diagnostic assay for the early detection of lung cancer using sputum
Sponsors
Alquest
Quintiles, Inc.
Radiology Associates of Albuquerque
New Mexico Technical Institute of Mining and Technology
US Department of Veterans Affairs
Biomoda Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | March 2011 | 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). |
Countries
United States
Participant flow
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
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Labeling of Deep-Lung Sputum Samples With TCPP 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. | 128 |
| Total | 128 |
Baseline characteristics
| Characteristic | Single Arm Labeling of Deep-Lung Sputum Samples With TCPP |
|---|---|
| Age, Customized cohort 1 n=102 | 57.2 years STANDARD_DEVIATION 11.6 |
| Age, Customized cohort 2 n=26 | 61.5 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 128 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 128 |
| serious Total, serious adverse events | 0 / 128 |
Outcome results
Primary
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.
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Single Arm Labeling of Deep-Lung Sputum Samples With TCPP | 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. | Sensitivity | 77.9 percentage |
| Single Arm Labeling of Deep-Lung Sputum Samples With TCPP | 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. | Specificity | 65.7 percentage |
| Single Arm Labeling of Deep-Lung Sputum Samples With TCPP | 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. | Accuracy | 81.3 percentage |