Specimens for Lung Cancer Panel Design
ConditionLung Nodules
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaverix Medical
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Individuals over 18 years old with indeterminate lung nodules identified on CT scans.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 3 trial groupsGroup A: Prior cancer
Group B: No prior cancer
Group C: Healthy volunteers
Trial outcomes
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.
Time frame
Two years from final case enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov