Specimens for Lung Cancer Panel Design

This is an observational study designed to determine the optimal combination of biomarkers and clinical data for the early detection, confirmation, and better treatment of lung cancer including minimizing recurrence.

Study Overview

• Status: Recruiting
• Conditions: Lung Nodules

Detailed Description

Peripheral venous blood and clinical data will be collected from consented subjects with lung nodules identified in radiology that are suspicious for lung cancer before invasive diagnosis or treatment is initiated. Various analyses will be conducted to determine which subset of biomarkers is most likely to be the most useful in the clinic. Attributes considered are accuracy (sensitivity, specificity, improvement over other methods) and ease of collection and transport. Results will not be reported to treating physicians and will not alter care of the patient.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: David Mallery; Phone Number: 858-245-4239; Email: dmallery@maverixmedical.com

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Recruiting
      • Maverix Medical
      • Contact: David Mallery; Phone Number: 858-245-4239; Email: dmallery@maverixmedical.com
      • Principal Investigator: Scott Morris, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals over 18 years old with indeterminate lung nodules identified on CT scans.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Prior cancer; Prior cancer history
No prior cancer; Indeterminant lung nodules with no prior history of cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Test performance	Analytical validity, clinical validity, and clinical utility. Ability to correctly re-risk indeterminate nodules and ability to change clinical care based on hypothetical treatment plans for different test outcomes. Actual test results will not be provided to physicians, and actual care will not be affected.	Two years from final case enrollment

Collaborators and Investigators

• Sponsor: Maverix Medical
• Investigators: Principal Investigator: Scott Morris, PhD, Maverix Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 3, 2026
• First Submitted That Met QC Criteria: February 3, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MXDX008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Need to eliminate issues with identifiable information in sequencing data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No