Specimens for Lung Cancer Panel Design
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Maverix Medical
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- Test performance
Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
- •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.
- •Is currently pregnant
Exclusion Criteria
- Not provided
Arms & Interventions
Prior cancer
Prior cancer history
No prior cancer
Indeterminant lung nodules with no prior history of cancer
Healthy volunteers
Healthy volunteers
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported