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. (BA-004)

bioAffinity Technologies

Status: Not yet enrolling

Conditions: Lung Cancer (Diagnosis)

Treatments: Other: Standard medical treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168993

BA-004

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,063 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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 6 weeks 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 distal (subsegmental) endobronchial nodule or 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,063 participants in 1 patient group

Single

Experimental group

Description:

Diagnostic testing of sputum sample provided by subject

Treatment:

Other: Standard medical treatment

Other: Standard medical treatment