Lung CancerPhase 1/2NCT00894127
Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
A Phase 1/2 study testing CyPath in people with Lung Cancer, run by Biomoda Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- CyPath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Mar 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Radiology Associates of Albuquerque
Albuquerque, New Mexico, 87109
Helen F. Graham Cancer Center, Christiana Care Health System
Newark, Delaware, 19713
Waterbury Pulmonary Research
Waterbury, Connecticut, 06708
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- CyPath
- Keywords
- Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyPathDevice
CyPath diagnostic assay for the early detection of lung cancer using sputum
| Study group | Role | What they receive |
|---|---|---|
| CyPath Assay of Deep-Lung Sputum Sample | Experimental | 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. Receives: Device: CyPath |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: March 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startMar 2009
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomoda Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alquest, Quintiles, Inc., Radiology Associates of Albuquerque, New Mexico Technical Institute of Mining and Technology, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Constance Dorian, BS Biology, Study directorLara Patriquin, MD, Principal investigator, Radiology Associates of AlbuquerquqeThomas Bauer, MD, Principal investigator, Helen F Graham Cancer Center, Christiana Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894127
- Sponsor's protocol ID
- MODA-001
- Status last verified
- Oct 2019
- First submitted
- 4 May 2009
- Last updated
- 30 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
- ClinicalTrials.gov ID
- NCT00894127
- Acronym / sponsor ID
- MODA-001
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Biomoda Inc.Industry (pharma, biotech, devices)
- Collaborators
- Alquest, Quintiles, Inc., Radiology Associates of Albuquerque, New Mexico Technical Institute of Mining and Technology, US Department of Veterans Affairs
- Study start
- Mar 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Posted 22 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CyPath Assay of Deep-Lung Sputum Sample | Experimental | Device: CyPathDeep-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Cohort 2: Known Lung Cancer
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyPathCyPath diagnostic assay for the early detection of lung cancer using sputum | Device | CyPath Assay of Deep-Lung Sputum Sample |
Primary outcome
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.
Time frame: 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").
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Constance Dorian, BS Biology study director
Lara Patriquin, MD principal investigator
Radiology Associates of Albuquerquqe
Thomas Bauer, MD principal investigator
Helen F Graham Cancer Center, Christiana Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CyPath in people with Lung Cancer, run by Biomoda Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: March 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.