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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.

Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well the FlowPath Lung test finds lung cancer using sputum, or mucus coughed up from the lungs. It is for people at high risk for lung cancer who have lung nodules (small spots) found on a CT scan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can sign a consent form and follow study requirements.
  • Are 50 to 80 years old.
  • Smoke now, or quit within the past 15 years, and have smoked at least 20 pack-years. This means, for example, one pack a day for 20 years.
  • Have a lung nodule larger than 6 mm but smaller than 30 mm on a CT scan. If there are several nodules, the most concerning one must be in this size range.
  • The nodule is new, is growing, or has stayed the same for no more than 6 months.
  • Will give a mucus sample within 12 weeks (3 months) of the CT scan done before the study.
  • Will provide contact information so the study doctor or treating doctors can obtain needed records about regular follow-up care.

Who can't join

  • Cannot cough hard enough to provide a mucus sample.
  • The main nodule looks hazy or partly solid on CT, or the nodule larger than 6 mm but smaller than 30 mm is perifissural (along a seam between parts of the lung).
  • Have 5 or more lung nodules larger than 4 mm.
  • Have a weakened immune system or rheumatoid arthritis, a disease that causes joint swelling.
  • Had lung cancer in the past 5 years or another cancer in the past 2 years, except non-melanoma skin cancer. Long-term medicine to prevent cancer, such as tamoxifen, does not rule you out.
  • Have angina (chest pain from reduced blood flow to the heart) with very little activity.
  • Are pregnant or plan to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Is able to give signed informed consent and comply with study requirements. 2. Is high risk for getting lung cancer: 1. ≥50 - 80 years of age. 2. 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. 3. 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 12 weeks (3 months) of the prestudy baseline CT scan. 3a) Nodule is either new, increasing, or stable for ≤ 6 months. 3b) In cases where a person has multiple nodules as determined by CT scan, the subject's most suspicious nodule is \>6 to \<30 mm in diameter. 4\) Is willing to provide contact information to the study PI or the treating physician(s) who can release required medical information related to SOC follow-up. Exclusion Criteria: 1. Is unable to cough with sufficient exertion to produce a sputum sample (e.g., due to severe obstructive lung disease). 2. The dominant nodule is ground glass or part solid as determined by CT scan. 3. Has 5 or more nodules sized \>4 mm. 4. The nodule sized \>6 to \<30 mm in diameter is a perifissural nodule. 5. Is immunosuppressed. 6. Has rheumatoid arthritis. 7. 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. 8. Has angina with minimal exertion. 9. Is currently pregnant or planning on becoming pregnant during this study.

Study sites (11)

CA

CO

FL

IL

OH

PA

TX

WI