Lung NodulesNCT07401797
Specimens for Lung Cancer Panel Design
An observational study of Lung Nodules, run by Maverix Medical at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Nodules
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2024to 31 Dec 2029
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals over 18 years old with indeterminate lung nodules identified on CT scans.
Who may be able to join
- 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
- Ability of the site to collect and process blood per protocol Exclusion
Show all 26Show fewer
- 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
- 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
- The patient has one or more nodules with a Mayo SPN risk over 50% or a diameter of 30mm or greater.
- The patient has received surgical prep, including antibiotics, anesthesia, etc. Fasting is not exclusionary.
- 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
- 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
- Ability to understand the study and sign an informed consent form
- Relevant clinical data accessible
- Ability and willingness to safely donate up to 40 mL of blood
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Maverix Medical
Phoenix, Arizona, 85004
David Mallery, 858-245-4239, dmallery@maverixmedical.com
Scott Morris, PhD
About this study
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.
Read the 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.
- Conditions
- Lung Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prior cancer | Prior cancer history | |
| No prior cancer | Indeterminant lung nodules with no prior history of cancer | |
| Healthy volunteers | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two years from final case enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start7 Aug 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NodulesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maverix Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Morris, PhD, Principal investigator, Maverix Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401797
- Sponsor's protocol ID
- MXDX008
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need to eliminate issues with identifiable information in sequencing data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specimens for Lung Cancer Panel Design
- ClinicalTrials.gov ID
- NCT07401797
- Acronym / sponsor ID
- MXDX008
- Conditions
- Lung Nodules
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Maverix MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Feb 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prior cancer | – | –Prior cancer history |
| No prior cancer | – | –Indeterminant lung nodules with no prior history of cancer |
| Healthy volunteers | – | –Healthy volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over 18 years old with indeterminate lung nodules identified on CT scans.
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Test performance
Time frame: Two years from final case enrollment
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.
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 10 Feb 2026.
- Individual participant dataSharing planned: Undecided. Need to eliminate issues with identifiable information in sequencing data.
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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.
Scott Morris, PhD principal investigator
Maverix Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Nodules, run by Maverix Medical at 1 site 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 26 inclusion and 0 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 David Mallery (858-245-4239, dmallery@maverixmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test performance (time frame: Two years from final case enrollment). 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 10 Feb 2026; AzTrials last refreshed its copy on 30 Oct 2026.