Actively Recruiting
Specimens for Lung Cancer Panel Design to Improve Early Detection and Treatment
Led by Maverix Medical · Updated on 2026-02-10
2000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting an observational study to improve early detection, confirmation, and treatment of lung cancer by finding the best combination of biomarkers and clinical data. The study focuses on people with lung nodules suspicious for cancer and aims to reduce cancer recurrence by identifying useful markers that can be easily collected and transported. This research is sponsored by Maverix Medical and does not affect patient care. Participants will provide peripheral blood samples and clinical information before any invasive diagnosis or treatment starts. The study includes three groups: people with prior cancer, those with indeterminate lung nodules but no prior cancer, and healthy volunteers. The collected samples will undergo various analyses to find the most accurate and practical biomarkers for clinical use. During the study, participants will donate blood and share relevant medical data. Researchers will not report results back to treating physicians or alter patient care. The primary measure is test performance evaluated two years after the last participant enrolls. Participants' involvement includes following planned medical procedures or surveillance for their nodules, and the study will track outcomes over time without impacting their usual treatment.
CONDITIONS
Brief Title
Specimens for Lung Cancer Panel Design
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Have at least one indeterminate lung nodule 5 mm or larger with a Mayo SPN risk over 5%, identified by radiology, that has not been biopsied or treated by surgery
- Plan with your doctor to follow up the nodule by biopsy, PET scan, or surveillance within 7 months
- Able to understand the study and sign informed consent
- Relevant clinical data is accessible
- Able and willing to safely donate up to 40 mL of blood
- For prior cancer group: in remission from non-lung cancer for more than 5 years
- For healthy volunteers: able to donate blood and provide clinical data
You will not qualify if you...
- Lung nodules with Mayo SPN risk over 50% or diameter 30 mm or greater
- Received prior surgical preparation such as antibiotics or anesthesia
- Previous lung cancer diagnosis or metastasis to the lung (for prior cancer group)
- Lung nodule believed to be recurrence of prior cancer (for prior cancer group)
- Currently pregnant
- Currently a prisoner or becomes a prisoner during the study
- Under age 18, unable to consent, or require another person to consent on your behalf
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single time point
Participants provide peripheral venous blood and clinical data for analysis of biomarkers related to lung nodules.
1 visit (in-person)
Duration - Up to 2 years from final case enrollment
Participants are observed over time to evaluate test performance related to lung nodule outcomes without changes to their routine care.
Visits as part of routine care; no additional study visits required
Trial Site Locations
Total: 1 location
1
Maverix Medical
Phoenix, Arizona, United States, 85004
Actively Recruiting
Research Team
D
David Mallery
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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