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.

NCT07168993 | Recruiting

• 1 other identifier: BA-004
• Study Type: interventional
• Target: 2,063
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer (Diagnosis)

Keywords

Lung Cancer; Diagnostic Test; Sputum Assay

Outcome Measures

Primary Outcomes (1)

• Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum

  Evaluate the clinical performance (positive percent agreement \[PPA/sensitivity\] and negative percent agreement \[NPA/specificity\]) of the FlowPath Lung test in predicting lung cancer from the sputum of high-risk individuals with lung nodules

  From Baseline Sputum Sample provided by subject through 24 months follow up period.

Study Arms (1)

Single

EXPERIMENTAL

Diagnostic testing of sputum sample provided by subject

Other: Standard medical treatment

Interventions

Standard medical treatment OTHER

Standard of care follow up per institution

Also known as: Standard of care follow up per institution

Single

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is able to give signed informed consent and comply with study requirements.
• Is high risk for getting lung cancer:
• ≥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.
• a) 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.
• \) 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.

You may not qualify if:

• 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.
• Is immunosuppressed.
• Has rheumatoid arthritis.
• 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.
• Has angina with minimal exertion.
• Is currently pregnant or planning on becoming pregnant during this study.

Sponsors & Collaborators

• bioAffinity Technologies Inc.: lead

Study Sites (3)

Clinical Research Associates of Central Pennsylvania

DuBois, Pennsylvania, 15801, United States

RECRUITING

Audie Murphy VA Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Disease

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Zannes

  bioAffinity Technologies Inc.

  STUDY CHAIR

Central Study Contacts

Xavier T Reveles, MS, CG(ASCP)

CONTACT

210-698-5334; xr@bioaffinitytech.com

Stacy K Stanek

CONTACT

612-716-7666; stacy.stanek@harvestiro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: February 25, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (3)