Blood and clinical data collection to design a lung nodule biomarker panel

Specimens for Lung Cancer Panel Design

This project will test blood biomarkers plus clinical information to see if they can better detect and confirm lung cancer in people with suspicious lung nodules before any invasive diagnosis or treatment.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Maverix Medical (Industry-sponsored)
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT07401797 on ClinicalTrials.gov

What this trial studies

This observational study enrolls people with indeterminate lung nodules identified on imaging and collects peripheral venous blood (about 40 mL) and relevant clinical data before any biopsy or surgery. Eligible nodules must be ≥5 mm with a Mayo SPN risk >5% but not extremely high risk or very large nodules, and participants should have planned follow-up (biopsy, PET, or surveillance) within about seven months. Collected samples will undergo multiple laboratory analyses to find the optimal subset of biomarkers based on accuracy (sensitivity, specificity, improvement over other methods) and practical considerations like ease of collection and transport. Results are for research only, will not be shared with treating physicians, and will not change patient care.

Who should consider this trial

Good fit: People with at least one indeterminate lung nodule ≥5 mm and a Mayo SPN risk >5%, who have not had prior cancer, have not yet undergone biopsy or surgery, can give 40 mL of blood, and have planned follow-up within the next seven months are ideal candidates.

Not a fit: Patients with very high-risk or large nodules (Mayo SPN risk >50% or diameter ≥30 mm), those with a prior cancer diagnosis, or those who have already begun surgical prep are excluded and unlikely to benefit from the biomarker findings.

Why it matters

Potential benefit: If successful, this could enable a blood-based test that helps detect and confirm lung cancer earlier and reduce unnecessary invasive procedures.

How similar studies have performed: Similar approaches using circulating tumor DNA and protein or multi-analyte biomarker panels have shown promise in early studies but have not yet produced a definitive, widely adopted blood test for early lung cancer.

Eligibility criteria

6.1 Criteria for the no prior cancer suspicious nodule arm

Inclusion:

1. The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery.
2. The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months.
3. Ability to understand the study and sign an informed consent form
4. Relevant clinical data accessible
5. Ability and willingness to safely donate 40 mL of blood
6. Ability of the site to collect and process blood per protocol Exclusion

1\. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.

2\. The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.

3\. Previous cancer diagnosis of any origin. 4. Is currently pregnant 5. Is currently a prisoner or becomes a prisoner at any point during the study 6. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf 6.2 Criteria for the previous cancer suspicious nodule arm

Inclusion:

1\. The patient has at least one indeterminant nodule with a diameter greater than or equal to 5mm and a Mayo SPN risk greater than 5%, identified by radiology, that has not been biopsied or undergone surgery.

2\. The patient and the treating physician intend to follow up on the nodule with a biopsy procedure, PET scan, or active surveillance, with the procedure or next surveillance planned within the next 7 months.

3\. The patient has been in remission for a previous cancer not of lung origin for more than 5 years.

4\. Ability to understand the study and sign an informed consent form 5. Relevant clinical data accessible 6. Ability and willingness to safely donate 40 mL of blood 7. Ability of the site to collect and process blood per protocol Exclusion

1. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
2. The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.
3. Previous cancer diagnosis in the lung (either of lung origin or metastasis to the lung).
4. The treating physician believes the lung nodule is a recurrence of a previously diagnosed cancer.
5. Is currently pregnant
6. Is currently a prisoner or becomes a prisoner at any point during the study
7. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf

6.3 Criteria for the healthy volunteer arm

Inclusion:

1. Ability to understand the study and sign an informed consent form
2. Relevant clinical data accessible
3. Ability and willingness to safely donate up to 40 mL of blood
4. The ability of the site to collect and process blood per protocol Exclusion

1\. Is currently pregnant 2. Is currently a prisoner or becomes a prisoner at any point during the study 3. Is under age 18, is unable to consent, or requires a different person or entity to consent on their behalf

Where this trial is running

Phoenix, Arizona

• Maverix Medical — Phoenix, Arizona, United States (Recruiting)

Study contacts

• Principal investigator: Scott Morris, PhD — Maverix Medical
• Study coordinator: David Mallery

Conditions Lung Nodules