NCT07401797

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
43mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Aug 2024Dec 2029

Study Start

First participant enrolled

August 7, 2024

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 10, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

February 3, 2026

Last Update Submit

February 3, 2026

Conditions

Lung Nodules

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Prior cancer

Prior cancer history

No prior cancer

Indeterminant lung nodules with no prior history of cancer

Healthy volunteers

Healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.
  • 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.
  • Ability to understand the study and sign an informed consent form
  • Relevant clinical data accessible
  • Ability and willingness to safely donate 40 mL of blood
  • \. The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
  • \. 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
  • \. 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.
  • \. 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.
  • \. The patient has been in remission for a previous cancer not of lung origin for more than 5 years.
  • The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
  • Previous cancer diagnosis in the lung (either of lung origin or metastasis to the lung).
  • The treating physician believes the lung nodule is a recurrence of a previously diagnosed cancer.
  • Is currently pregnant
  • Is currently a prisoner or becomes a prisoner at any point during the study
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maverix Medical

Phoenix, Arizona, 85004, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Under 40ml of blood from a single venipuncture or collection

Study Officials

  • Scott Morris, PhD

    Maverix Medical

    PRINCIPAL INVESTIGATOR

Central Study Contacts

David Mallery

CONTACT

858-245-4239dmallery@maverixmedical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

August 7, 2024

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

February 10, 2026

Record last verified: 2026-01

Locations

US(1)