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NCT05462795 · ClinicalTrials.gov registry record
Liquid Biopsy for Early Non-small Lung Cancer Detection
A clinical trial, sponsored by University of Arizona.
- Completed
- Registry status
- 171
- Enrollment target
NCT05462795: Completed study, sponsored by University of Arizona.
NCT05462795 is a clinical trial that has completed, run by University of Arizona. The registered enrollment target is 171 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05462795 has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- 171 participants
- Enrollment target
Study Summary
This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.
Primary Outcome
The patients with indeterminate nodules will be used to separately estimate the sensitivity (in those with lung cancer) and specificity (in those without lung cancer). At least 35 patients with lung cancer will provide an estimate of the standard error of the sensitivity \< 0.09. Specificity will also be assessed in the normal controls (healthy volunteer cohort) using exact binomial confidence intervals.
Interventions
- DIAGNOSTIC_TEST Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule
- DIAGNOSTIC_TEST Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection
- DIAGNOSTIC_TEST Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer
- DIAGNOSTIC_TEST Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2022-08-02 |
| Est. Completion | 2024-03-22 |
What the finished NCT05462795 record still lists
NCT05462795 is an observational study that tracks outcomes without assigning an intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule is the first listed.
NCT05462795 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05462795 about?
NCT05462795 is a clinical study titled "Liquid Biopsy for Early Non-small Lung Cancer Detection". This clinical trial will assess the performance of a liquid biopsy assay to identify cancer in indeterminant pulmonary nodules identified by CT screening of high-risk individuals and evaluate the capability of the liquid biopsy assay to monitor response to surgical resection.
What is the current status of trial NCT05462795?
This trial is currently completed. The enrollment target is 171 participants. The study started on 2022-08-02. Estimated completion is 2024-03-22.
What interventions are being tested in trial NCT05462795?
The interventions under investigation include: Liquid biopsy for aberrant DNA methylation analysis - Indeterminate pulmonary nodule (DIAGNOSTIC_TEST), Liquid biopsy for aberrant DNA methylation analysis - Known lung cancer for surgical resection (DIAGNOSTIC_TEST), Liquid biopsy for aberrant DNA methylation analysis - Healthy volunteer (DIAGNOSTIC_TEST), Liquid biopsy for aberrant DNA methylation analysis - Benign lung disease (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05462795?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
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