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.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorbioAffinity Technologies Inc.

About this trial

Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, \>6 to \<30 mm in Diameter, Determined by LDCT.

Eligibility criteria

Qualifiers

Is able to give signed informed consent and comply with study requirements.

≥50 - 80 years of age.

current smoker with smoking history of at least 20 pack-years or current non-smoker with smoking history of at least 20 pack-years who quit smoking within the past 15 years.

Has a >6 to <30 mm diameter lung nodule (found by lung cancer screening or found incidentally by CT scan) as determined by CT and is willing to provide a sputum sample for FlowPath Lung test within 6 weeks of the prestudy baseline CT scan.

Disqualifiers

Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).

The dominant nodule is ground glass or part solid as determined by CT scan.

Has 5 or more nodules sized >4 mm.

The nodule sized >6 to <30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.

Trial design

Treatments tested in this trial

  • Standard medical treatment
  • Standard medical treatment

Treatment groups

2,063 Participants
are divided into 1 treatment group

Sponsors and collaborators