Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.
← catalyst calendarNCT07168993 · readout in 955 d
Sponsored by bioAffinity Technologies Inc. (industry) · BIAF — their whole pipeline →. With Precision Pathology Laboratory Services (PPLS), HiRO (Harvest Integrated Research Organization).
Phase
Not applicable
Status
Recruiting
Study type
Interventional
Design
Na · None · Diagnostic
Enrollment
2,063estimated
Sites
11
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-25 | actual | When the study began enrolling |
| Primary completion | 2029-04-01 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-07-01 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Lung Cancer (Diagnosis)
Interventions
- Other: Standard medical treatment — also filed as Standard of care follow up per institution
- Other: Standard medical treatment — also filed as Follow up SOC
Primary outcome
what the primary-completion date above is the date OFEvaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
measured From Baseline Sputum Sample provided by subject through 24 months follow up period.
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