Clinical trial · Observational
Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath Lung Assay
Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients
- 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)
There are numerous Department of Defense (DoD) beneficiaries enrolled in the various lung cancer screening programs across the DoD. This study may enable patients to forego annual CT lung cancer screening or help to predict cancerous nodules without interventional procedures. This is a prospective observational study of sputum cytology using flow cytometry to analyze sputum samples collected from patients in the active military who are undergoing annual lung cancer screening. The primary objective of this study is to analyze the cellular profiles of sputum samples collected from the Acapella® airway assist device in patients at higher risk for lung cancer. The target population are high risk patients for developing lung cancer, age 50-80 with a significant smoking history.
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 (0)
[]Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- 12 months
- description
- The primary objective of this study is to analyze the cellular profiles of sputum samples collected from the Acapella® airway assist device in patients at higher risk for lung cancer.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Active Military * 50-80 years-of-age * Smoking history of 20-pack-years or more * If not currently smoking cigarettes, quit smoking within 15 years of giving sputum sample * Undergoing CT scan of chest as part of annual screening for lung cancer Exclusion Criteria: * Active respiratory illness in the preceding 2 weeks * Using antibiotics in the past 2 weeks * Unable to use Acapella device for sputum collection * Known history of lung cancer
References
Publications (5)
- BACKGROUNDGrayson M, Lai SC, Bederka LH, Araujo P, Sanchez J, Reveles XT, Rebel VI, Rebeles J. Quality-Controlled Sputum Analysis by Flow Cytometry. J Vis Exp. 2021 Aug 9;(174). doi: 10.3791/62785. PMID 34424239
- BACKGROUNDBederka LH, Sanchez JR, Rebeles J, Araujo PR, Grayson MH, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Humphreys J, Reveles XT, Rebel VI. Sputum analysis by flow cytometry; an effective platform to analyze the lung environment. PLoS One. 2022 Aug 17;17(8):e0272069. doi: 10.1371/journal.pone.0272069. eCollection 2022. PMID 35976857
- BACKGROUNDElzi DJ, Bauta WE, Sanchez JR, Das T, Mogare S, Zannes Fatland P, Iza M, Pertsemlidis A, Rebel VI. Identification of a novel mechanism for meso-tetra (4-carboxyphenyl) porphyrin (TCPP) uptake in cancer cells. FASEB J. 2021 Mar;35(3):e21427. doi: 10.1096/fj.202000197R. PMID 33629776
- RESULTLemieux ME, Reveles XT, Rebeles J, Bederka LH, Araujo PR, Sanchez JR, Grayson M, Lai SC, DePalo LR, Habib SA, Hill DG, Lopez K, Patriquin L, Sussman R, Joyce RP, Rebel VI. Detection of early-stage lung cancer in sputum using automated flow cytometry and machine learning. Respir Res. 2023 Jan 21;24(1):23. doi: 10.1186/s12931-023-02327-3. PMID 36681813
- 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