Evaluating a biomarker model for assessing lung nodules
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study
This study is testing a new combined biomarker model to see if it can better help doctors understand the risk of indeterminate lung nodules compared to the current method.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Vanderbilt-Ingram Cancer Center Academic / other |
| Locations | 4 sites (Aurora, Colorado and 3 other locations) |
| Trial ID | NCT06074133 on ClinicalTrials.gov |
What this trial studies
This prospective, multicenter observational study aims to estimate the clinical utility of a combined biomarker model (CBM) for risk stratification of indeterminate pulmonary nodules (IPNs). It will compare the CBM score, which includes hs-CYFRA 21-1 and radiomics, to the established Mayo Model. The study also seeks to establish standard operating procedures and protocols for future randomized control trials, ensuring that data collection and analysis are efficient and clinically relevant. Participants will undergo blood collection and chest CT scans as part of the evaluation process.
Who should consider this trial
Good fit: Ideal candidates are adults over 21 with intermediate-risk indeterminate pulmonary nodules measuring 8-30mm.
Not a fit: Patients with pure ground glass nodules, those currently undergoing cancer therapy, or with a history of primary lung cancer in the last 5 years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of risk assessment for patients with indeterminate pulmonary nodules, leading to better clinical decision-making.
How similar studies have performed: Other studies have shown promise in using biomarker models for lung nodule assessment, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults \> 21 y/o * IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model * Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model * Solid nodules or part-solid nodules with solid component \>=8mm * CT scan with nodule of concern performed within 60 days of enrollment Exclusion Criteria: Pure ground glass nodule or subsolid nodule with solid component \<8mm * Currently on therapy for any cancer * History of primary lung cancer within the last 5 years * Multiple nodules highly suspicious for metastatic disease * Other malignancy within the last 2 year - Excluding skin cancer other than melanoma * Pregnant women * Prisoners * Inability to provide informed consent * Serologic evidence of active fungal infection
Where this trial is running
Aurora, Colorado and 3 other locations
- Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States (Not_yet_recruiting)
- University of Colorado — Aurora, Colorado, United States (Recruiting)
- Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States (Recruiting)
- VA Tennessee Valley Healthcare Center — Nashville, Tennessee, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Eric Grogan, MD — Vanderbilt University/Ingram Cancer Center
- Study coordinator: Vanderbilt-Ingram Services for Timely Access
- Email: cip@vumc.org
- Phone: 800-811-8480
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.