Clinical trial · Observational
Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is optimization of the assay to discriminate between cancer cells and non-cancer cells in sputum samples by the performance of experiments that will determine methods to liquefy sputum, select proper fixatives and buffers, determine the efficacy of use of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the use of flow cytometry for high-throughput, and in the establishment of cell count and sputum cell populations in patient samples. The secondary objective of this study is comparison of the characteristics of sputum from three cohorts labeled with CyPath Lung to determine differential characteristics between samples taken from Participants who are not at high risk for lung cancer, Participants at high risk for lung cancer who are free of the disease and Participants with confirmed lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Healthy Cohort
- description
- Participants who have smoked less than 5 pack-years, have quit smoking for more than 15 years and have no known lung diseases.
- label
- High-risk Cohort
- description
- Participants who are at high risk for lung cancer including current smokers who have smoked for more than 30 pack-years and have not quit within 15 years.
- label
- Cancer Cohort
- description
- Participants who have been diagnosed with lung cancer.
Primary outcomes (1)
- measure
- Assay Optimization
- timeFrame
- 320 days
- description
- Assay optimization for methods to liquefy sputum by chemical dissociation, select proper fixatives and buffers, the efficacy of use of methyl-beta-cyclodextrin (MBCD) in sputum processing and determine the cell count in sputum. To ensure sample adequacy as deep lung, samples will be analyzed by a cytologist who will perform PAP staining for the presence of macrophages. Macrophages are an indication that the sputum sample is from deep within the lungs. Findings of the experiments and comparative study will not be used in the diagnosis or treatment of Participants.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Each subject must meet the following criteria to be enrolled in this study: * Male or female * 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 three cohorts in the study: * Healthy Cohort: Current non-smoker who has smoked less than 5 pack-years in his or her lifetime, and if smoked, has quit for more than 15 years ago and who has no known lung disease. * High Risk Cohort: Current smoker, or individual who has quit smoking less than 15 years before study start, who has smoked more than 30 pack-years in his or her lifetime. * Cancer Cohort: Individual who has been diagnosed by a physician with lung cancer. Exclusion Criteria: Participants who meet any of the following criteria will be excluded from the study: * Lung disease * Angina with minimal exertion * Pregnancy * Have or have had cancer other than lung cancer * Worked in the mining Industry
References
Publications (1)
- RESULTPatriquin L, Merrick DT, Hill D, Holcomb RG, Lemieux ME, Bennett G, Karia B, Rebel VI, Bauer T 2nd. Early Detection of Lung Cancer with Meso Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum. J Thorac Oncol. 2015 Sep;10(9):1311-1318. doi: 10.1097/JTO.0000000000000627. PMID 26200451