Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphine (TCPP) for Detection of Lung Cancer
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable lung-cancer
Started Mar 2015
Shorter than P25 for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 4, 2015
CompletedFirst Posted
Study publicly available on registry
March 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 17, 2015
CompletedJuly 14, 2015
June 1, 2015
1 month
March 4, 2015
May 5, 2015
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 months
Study Arms (1)
CyPath® Assay of Deep-Lung Sputum Sample
EXPERIMENTALDeep-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.
Interventions
CyPath® diagnostic assay for the early detection of lung cancer using sputum
Eligibility Criteria
You may qualify if:
- Participants who have never smoked nor have known lung diseases
You may not qualify if:
- Severe obstructive lung disease
- Angina with minimal exertion
- Pregnancy
- Have or have had cancer other than lung cancer
- Worked in the mining Industry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- bioAffinity Technologies Inc.lead
- Radiology Associates of Albuquerquecollaborator
Study Sites (1)
Radiology Associates of Albuquerque (RAA)
Albuquerque, New Mexico, 87109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bijal Karia, PhD Director of Research
- Organization
- bioAffinity Technologies Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Lara Patriquin, MD
Radiology Associates of Albuquerque
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2015
First Posted
March 13, 2015
Study Start
March 1, 2015
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 14, 2015
Results First Posted
June 17, 2015
Record last verified: 2015-06