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NCT03837600 · ClinicalTrials.gov registry record
Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer
A clinical trial, sponsored by bioAffinity Technologies.
- Completed
- Registry status
- 197
- Enrollment target
NCT03837600: Completed study, sponsored by bioAffinity Technologies.
NCT03837600 is a clinical trial that has completed, run by bioAffinity Technologies. The registered enrollment target is 197 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03837600 has completed, sponsored by bioAffinity Technologies.
- COMPLETED
- Registry status
- 197 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 197 participants |
| Start Date | 2016-09-22 |
| Est. Completion | 2018-08-15 |
What the finished NCT03837600 record still lists
NCT03837600 is an observational study that tracks outcomes without assigning an intervention. The registered 197 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03837600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03837600 about?
NCT03837600 is a clinical study titled "Sputum Labeling Utilizing Synthetic Meso-Tetra (4-Carboxyphenyl) Porphyrin (TCPP) for Detection of Lung Cancer". 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-b...
What is the current status of trial NCT03837600?
This trial is currently completed. The enrollment target is 197 participants. The study started on 2016-09-22. Estimated completion is 2018-08-15.
Who is sponsoring clinical trial NCT03837600?
This trial is sponsored by bioAffinity Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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