Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Sā¦ (NCT07168993) | Clinical Trial Compass
RecruitingNot Applicable
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.
United States2,063 participantsStarted 2026-02-25
Plain-language summary
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.
Who can participate
Age range50 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Is able to give signed informed consent and comply with study requirements.
ā. Is high risk for getting lung cancer:
ā. ā„50 - 80 years of age.
ā. 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.
ā. 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.
Exclusion criteria
ā. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease).
ā. The dominant nodule is ground glass or part solid as determined by CT scan.
ā. Has 5 or more nodules sized \>4 mm.
ā. The nodule sized \>6 to \<30 mm in diameter is a distal (subsegmental) endobronchial nodule or a perifissural nodule.
ā. Is immunosuppressed.
ā. Has rheumatoid arthritis.
ā. Had lung cancer diagnosis in the past 5 years or any other cancer (other than non-melanoma skin cancer) in the past 2 years. A subject on long-term medications used for prevention of cancer, such as Tamoxifen for breast cancer, is not excluded.
What they're measuring
1
Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum
Timeframe: From Baseline Sputum Sample provided by subject through 24 months follow up period.