Blood test and imaging to guide care for unclear lung nodules
Clinical Utility of Biomarkers Driven Management of Indeterminate Pulmonary Nodules
People with uncertain lung nodules get a high-sensitivity blood biomarker plus detailed scan measurements to help guide whether to watch, biopsy, or treat.
Quick facts
| Grant type | R01 grant |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Vanderbilt University Medical Center NIH-funded |
| Lab location | 1 site (Nashville, United States) |
| Project ID | NIH-11308730 on NIH RePORTER |
What this research studies
If you join, doctors will combine a high-sensitivity blood test (hs-CYFRA 21-1), computerized imaging measurements, and your clinical information to produce a post-test probability of cancer. Participants are randomly assigned to usual care or to have the biomarker result shared with them and their providers to inform management decisions. The trial plans to enroll 440 people with intermediate-risk nodules (10–70% chance of cancer) across four medical centers. Researchers will compare how often people undergo invasive procedures and how quickly they reach a diagnosis between the two groups.
Who could benefit from this research
Good fit: Adults with indeterminate pulmonary nodules estimated to be in the intermediate risk range (about 10–70% chance of cancer) are the intended candidates for this work.
Not a fit: People with nodules judged clearly benign or clearly malignant outside the 10–70% risk range, or those unable to attend participating centers or provide blood samples, are unlikely to benefit from joining.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary biopsies and procedures and shorten time to a diagnosis for people with indeterminate lung nodules.
How similar studies have performed: Prior observational and validation studies showed promising performance for the hs-CYFRA 21-1 biomarker and imaging signature, but a randomized trial using them to guide nodule management is novel.
Where this research is happening
Nashville, United States
- Vanderbilt University Medical Center — Nashville, United States (Active)
Researchers
- Principal investigator: Grogan, Eric L — Vanderbilt University Medical Center
- Study coordinator: Grogan, Eric L
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.