Lung CancerNCT02388074
Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
A study testing CyPath® in people with Lung Cancer, run by bioAffinity Technologies Inc. at 1 site in United States.
Trial summary
This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer Assay to detect lung cancer cells from deep lung sputum. 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
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Apr 2015
- Phase
- Interventional
- 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
- Participants who have never smoked nor have known lung diseases
Who cannot join
- Severe obstructive lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- Worked in the mining Industry
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiology Associates of Albuquerque (RAA)
Albuquerque, New Mexico, 87109
About this study
Official title: Sputum Labeling Utilizing Synthetic Meso Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer Assay to detect lung cancer cells from deep lung sputum.
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 is to determine the the presence or absence of red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples using the CyPath® Early Lung Cancer Detection Assay from one cohort of Participants who are healthy. The results from this trial will be compared with two additional cohorts of Participants including individuals at high risk for lung cancer and individuals diagnosed with lung cancer. Collection of the sputum samples from high-risk individuals and lung cancer patients is complete (NCT00894127).
Participants who satisfy the inclusion/exclusion criteria will be enrolled into the study and assigned to the healthy cohort. The sputum samples will be collected at the study site or at the Participant's home after explanation of the collection procedure by study staff. Samples will be identified with an identification number blinding the sample identity. Each subject's sputum specimen will be processed onto 13 microscope slides at the University of Texas Health Science Center of San Antonio (UTHSCSA) Laboratory. The UTHSCSA laboratory will process each sputum sample onto slides using the ThinPrep T2000 processor for use in the CyPath® Early Lung Cancer Detection Assay.
Twelve slides from each sputum sample will be labeled with CyPath®. One slide will be used to preform PAP staining for the presence of macrophages. Macrophages are an indication that the sputum sample is from deep within the lungs. A cytopathologist will review the slide and record results on a specimen adequacy form. bioAffinity researchers who will be blinded as to the Participant's identity will perform the CyPath® labeling and scoring of the slides. The study results of the healthy cohort will be used for comparison with the results of a closed study in which the sputum from individuals at high risk of lung cancer and individuals diagnosed with lung cancer was compared.
Findings of the CyPath® assay will not be used in the diagnosis or treatment of Participants.
- 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.
CyPath®Device
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 healthy individuals who had no known lung disease, was labeled 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.
Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants
The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®.
Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- bioAffinity Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Radiology Associates of Albuquerque
- Responsible party
- Sponsor
- Investigators
- Lara Patriquin, MD, Principal investigator, Radiology Associates of Albuquerque
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02388074
- Sponsor's protocol ID
- MODA-002
- Status last verified
- Jun 2015
- First submitted
- 4 Mar 2015
- Last updated
- 14 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2015. 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
- NCT02388074
- Acronym / sponsor ID
- MODA-002
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Porphyrin, Fluorescence, Diagnostic, Sputum Cytology, Early Detection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- bioAffinity Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Radiology Associates of Albuquerque
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 13 Mar 2015 (estimated)
- Results
- Posted 17 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center study to assess the efficacy of CyPath® Early Detection Lung Cancer Assay to detect lung cancer cells from deep lung sputum.
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 is to determine the the presence or absence of red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples using the CyPath® Early Lung Cancer Detection Assay from one cohort of Participants who are healthy. The results from this trial will be compared with two additional cohorts of Participants including individuals at high risk for lung cancer and individuals diagnosed with lung cancer. Collection of the sputum samples from high-risk individuals and lung cancer patients is complete (NCT00894127).
Participants who satisfy the inclusion/exclusion criteria will be enrolled into the study and assigned to the healthy cohort. The sputum samples will be collected at the study site or at the Participant's home after explanation of the collection procedure by study staff. Samples will be identified with an identification number blinding the sample identity. Each subject's sputum specimen will be processed onto 13 microscope slides at the University of Texas Health Science Center of San Antonio (UTHSCSA) Laboratory. The UTHSCSA laboratory will process each sputum sample onto slides using the ThinPrep T2000 processor for use in the CyPath® Early Lung Cancer Detection Assay.
Twelve slides from each sputum sample will be labeled with CyPath®. One slide will be used to preform PAP staining for the presence of macrophages. Macrophages are an indication that the sputum sample is from deep within the lungs. A cytopathologist will review the slide and record results on a specimen adequacy form. bioAffinity researchers who will be blinded as to the Participant's identity will perform the CyPath® labeling and scoring of the slides. The study results of the healthy cohort will be used for comparison with the results of a closed study in which the sputum from individuals at high risk of lung cancer and individuals diagnosed with lung cancer was compared.
Findings of the CyPath® assay will not be used in the diagnosis or treatment of Participants.
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: CyPath®Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled 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 (1 listed)
- Participants who have never smoked nor have known lung diseases
Key exclusion criteria (5 listed)
- Severe obstructive lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- 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 |
|---|---|---|
| CyPath®CyPath® diagnostic assay for the early detection of lung cancer using sputum | Device | CyPath® Assay of Deep-Lung Sputum Sample |
Primary outcome
Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants
Time frame: 2 months
The presence or absence of red fluorescent (RFCs) cancer cells was evaluated in sputum samples from healthy individuals labeled with CyPath®. Testing for the study was performed at one study center to collect sputum samples from healthy individuals who have no known lung disease. Comparison of sputum specimens from one cohort of Participants who are healthy with two additional cohorts of Participants, including individuals at high risk for lung cancer and individuals diagnosed with lung cancer, that has already been completed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2015.
- 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.
Lara Patriquin, MD principal investigator
Radiology Associates of Albuquerque
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CyPath® in people with Lung Cancer, run by bioAffinity Technologies Inc. at 1 site 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 1 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 14 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2015). 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?
Number of Red Fluorescent [i.e., Cancer] Cells (RFCs) in Sputum From Healthy Participants (time frame: 2 months). 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 14 Jul 2015.