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.

NCT ID: NCT07168993

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2063 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2029-07-01

Brief 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.

Detailed 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.

Conditions

Lung Cancer (Diagnosis)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single

Diagnostic testing of sputum sample provided by subject

Group Type: EXPERIMENTAL

Standard medical treatment

Intervention Type: OTHER

Standard of care follow up per institution

Standard medical treatment

Intervention Type: OTHER

SOC per institution

Interventions

Standard medical treatment

Standard of care follow up per institution

Intervention Type: OTHER

Standard medical treatment

SOC per institution

Intervention Type: OTHER

Other Intervention Names

Standard of care follow up per institution; Follow up SOC

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 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

bioAffinity Technologies Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

BA-004

Identifier Type: -

Identifier Source: org_study_id