Lung Cancer (Diagnosis)BA-004NCT07168993
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.
A study testing Standard medical treatment in people with Lung Cancer (Diagnosis), run by bioAffinity Technologies Inc. at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer (Diagnosis)
- What is being tested?
- Standard medical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,063 participants
- Where
- 11 sitesUnited States
- Study dates
- 25 Feb 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
Who cannot join
- 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 perifissural nodule.
- Is immunosuppressed.
- Has rheumatoid arthritis.
Show all 9Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Bay Pines VA Healthcare System
Bay Pines, Florida, 33744
Sarah Crim, CCRC, 727-398-6661 ext. 17975, Sarah.Crim@va.gov
Stephen Clum, MD
- Recruiting
Dayton VA Medical Center
Dayton, Ohio, 45428
Joshua A Hamilton, MD, 937-268-6511, Joshua.Hamilton@va.gov
Joshua A Hamilton, MD
- Recruiting
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, 15801
Amber E. Witherow, RN, BSN, 814-661-8837 ext. 13208, awitherow@lunginnovations.com
Brian Sturgill, MSN, RN, 786-819-0780, brian.sturgill@va.gov
- Recruiting
VA Western Colorado Health Care System
Grand Junction, Colorado, 81501
Lisa Bertrand, RN, 970-242-0731 ext. 2314, Lisa.Bertrand@va.gov
Brandon Eccles, DO
- Recruiting
Miami VA Healthcare System
Miami, Florida, 33125
Gregory E. Holt, MD, PhD, 305-575-7000 ext. 13208, gregory.holt@va.gov
Brian Sturgill, MSN, RN, 786-819-0780, brian.sturgill@va.gov
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Alexandria A Cook, MD, (414) 955-6839, alcook@mcw.edu
Jonathan Kurman, MD
- Recruiting
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Angela Sells, 224-610-1458, Angela.Sells1@va.gov
Mutka Pant-Purohit, MD
- Recruiting
VA Palo Alto Health Care System
Palo Alto, California, 94304
Kalyani Raraviker, 650-493-5000 ext. 66447, Kalyani.Raravikar@va.gov
Ware Kuschner, MD
- Recruiting
Audie Murphy VA Medical Center
San Antonio, Texas, 78234
Sheila Habib, MD
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Jessica Pedroza, BSN, RN, OCN, 210-916-2995, jpedroza@hjf.org
Michael J Morris, MD
- Recruiting
James A. Haley Veterans' Hospital
Tampa, Florida, 33612
Lisa A Braun, Ph.D., APRN-BC, CCRP, FAANP, 813-872-2000, Lisa.Braun2@va.gov
Humayun Lodhi, MD
About this study
Official title: Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline
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.
Read the 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)
- Being tested
- Standard medical treatment
- Keywords
- Lung Cancer, Diagnostic Test, Sputum Assay
- Medical subject headings
- Lung Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard medical treatmentOther
Also called Standard of care follow up per institution
Standard of care follow up per institution
Standard medical treatmentOther
Also called Follow up SOC
SOC per institution
| Study group | Role | What they receive |
|---|---|---|
| Single | Experimental | Diagnostic testing of sputum sample provided by subject Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Baseline Sputum Sample provided by subject through 24 months follow up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start25 Feb 2026
- Primary completion1 Apr 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (Diagnosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,063 participants (estimated)
Sponsor and investigators
- Lead sponsor
- bioAffinity Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Precision Pathology Laboratory Services (PPLS), HiRO (Harvest Integrated Research Organization)
- Responsible party
- Sponsor
- Investigators
- Maria Zannes, Study chair, bioAffinity Technologies Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168993
- Sponsor's protocol ID
- BA-004
- Acronym
- BA-004
- Status last verified
- Oct 2026
- First submitted
- 5 Sep 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Early-Stage Lung Cancer in Sputum Using Flow Cytometry and an Automated Analysis Pipeline
- ClinicalTrials.gov ID
- NCT07168993
- Acronym / sponsor ID
- BA-004 / BA-004
- Conditions
- Lung Cancer (Diagnosis)
- Keywords
- Lung Cancer, Diagnostic Test, Sputum Assay
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,063 participants (estimated)
- Lead sponsor
- bioAffinity Technologies Inc.Industry (pharma, biotech, devices)
- Collaborators
- Precision Pathology Laboratory Services (PPLS), HiRO (Harvest Integrated Research Organization)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 1 Apr 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single | Experimental | Other: Standard medical treatmentDiagnostic testing of sputum sample provided by subject |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is able to give signed informed consent and comply with study requirements.
- Is high risk for getting lung cancer:
- 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.
Key exclusion criteria (9 listed)
- 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 perifissural nodule.
- Is immunosuppressed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard medical treatmentAlso: Standard of care follow up per institutionStandard of care follow up per institution | Other | Single |
| Standard medical treatmentAlso: Follow up SOCSOC per institution | Other | Single |
Primary outcome
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Zannes study chair
bioAffinity Technologies Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard medical treatment in people with Lung Cancer (Diagnosis), run by bioAffinity Technologies Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xavier T Reveles, MS, CG(ASCP) (210-698-5334, xr@bioaffinitytech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.