Clinical Trials in the USA / NCT07401797
Recruiting
Observational
Specimens for Lung Cancer Panel Design
NCT07401797 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Lung Nodules
Study 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.
Eligibility
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
Primary outcome measure(s)
- Test performance — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Maverix Medical | Phoenix | Arizona | Recruiting |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07401797 on ClinicalTrials.gov ↗ ← All trials in the USA