Recruiting

FlowPath Lung Test

Sponsor:

bioAffinity Technologies Inc.

Code:

NCT07168993

Conditions

Lung Cancer (Diagnosis)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Standard medical treatment

Standard medical treatment

Study Details

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)

Study ID

NCT07168993

Start date

Feb 25, 2026

Status verified date

Jul, 2026

Completion date

Jul 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2063 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Single

Diagnostic testing of sputum sample provided by subject

Interventions

Standard medical treatment

Standard of care follow up per institution

Standard medical treatment

SOC per institution

Primary outcome measure

  • Evaluate FlowPath Lung Test Detection of Early-Stage Lung Cancer in Sputum [ Time Frame: From Baseline Sputum Sample provided by subject through 24 months follow up period. ]

Central Contacts and Locations

Central contacts

Locations

VA Palo Alto Health Care System

Recruiting

Palo Alto, California, United States, 94304

Contacts

Principal Investigator:

Ware Kuschner, MD

VA Western Colorado Health Care System

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Principal Investigator:

Brandon Eccles, DO

Bay Pines VA Healthcare System

Recruiting

Bay Pines, Florida, United States, 33744

Contacts

Principal Investigator:

Stephen Clum, MD

Miami VA Healthcare System

Recruiting

Miami, Florida, United States, 33125

Contacts

Gregory E. Holt, MD, PhD

305-575-7000gregory.holt@va.gov

Brian Sturgill, MSN, RN

786-819-0780brian.sturgill@va.gov

Principal Investigator:

Gregory Holt, MD

James A. Haley Veterans' Hospital

Recruiting

Tampa, Florida, United States, 33612

Contacts

Lisa A Braun, Ph.D., APRN-BC, CCRP, FAANP

813-872-2000Lisa.Braun2@va.gov

Principal Investigator:

Humayun Lodhi, MD

Captain James A. Lovell Federal Health Care Center

Recruiting

North Chicago, Illinois, United States, 60064

Contacts

Principal Investigator:

Mutka Pant-Purohit, MD

Dayton VA Medical Center

Recruiting

Dayton, Ohio, United States, 45428

Contacts

Principal Investigator:

Joshua A Hamilton, MD

Clinical Research Associates of Central Pennsylvania

Recruiting

DuBois, Pennsylvania, United States, 15801

Contacts

Principal Investigator:

Sandeep Bansal, MD

Audie Murphy VA Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Principal Investigator:

Sheila Habib, MD

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Jessica Pedroza, BSN, RN, OCN

210-916-2995jpedroza@hjf.org

Principal Investigator:

Michael J Morris, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Alexandria A Cook, MD

(414) 955-6839alcook@mcw.edu

Principal Investigator:

Jonathan Kurman, MD

More Information

Sponsor

bioAffinity Technologies Inc.

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Lung Cancer
  • Diagnostic Test
  • Sputum Assay

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by bioAffinity Technologies Inc. on 2026-07-16.