A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules (NCT06074133) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
United States103 participantsStarted 2024-03-07
Plain-language summary
This is a prospective, multicenter observational study aim at estimating the potential clinical utility of the CBM and at establishing the SOPs and protocols for a future randomized control trial.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients with benign disease who underwent invasive diagnostic procedures.
Timeframe: Up to approximately 2 years
2
The time to diagnosis (in days) for patients with cancer.
Timeframe: Up to approximately 2 years
3
Measure time needed to provide the CBM Value to clinician
Timeframe: Up to approximately 2 years
4
Measure time needed to obtain hs CYFRA 21-1 values