Biomarker Model for Pulmonary Nodules
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how effectively a new biomarker model predicts the risk of indeterminate pulmonary nodules, which are small lung growths not clearly identified as cancerous or benign. Researchers seek to determine if this model surpasses current methods in assessing these nodules. The study seeks participants who have had a recent CT scan showing lung nodules measuring 8-30mm and are at an intermediate risk of being cancerous. Eligible participants should not have had lung cancer in the past five years or be undergoing cancer treatment. This trial will establish procedures for future testing of this model. As a Phase 2 trial, it focuses on assessing the new biomarker model's effectiveness in an initial, smaller group, offering participants a chance to contribute to potentially groundbreaking research.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve how we assess the risk of indeterminate pulmonary nodules, which are small, unclear growths in the lungs. Unlike traditional methods that mainly rely on imaging techniques, this new approach combines a biomarker model with high-sensitivity CYFRA 21-1 and radiomics, alongside the established Mayo Clinic model. This combination has the potential to provide a more accurate prediction of whether these nodules are likely to be cancerous, helping doctors make better-informed decisions and possibly reducing unnecessary surgeries or biopsies.
What evidence suggests that this biomarker model is effective for pulmonary nodules?
Research has shown that a combined biomarker model can assess cancer risk in individuals with unclear lung nodules (small lumps in the lung). This trial will evaluate participants using this model, which includes the Mayo risk score, a protein marker called hs-CYFRA 21-1, and a tool called radiomics that analyzes medical images to better identify potentially cancerous nodules. Studies have found that this method can reduce the need for invasive procedures, which are often expensive and risky. By integrating different types of information, the model provides a more complete picture of whether a nodule could be cancerous, potentially leading to earlier and more accurate diagnoses.12345
Who Is on the Research Team?
Eric Grogan, MD
Principal Investigator
Vanderbilt University/Ingram Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational
Participants undergo biomarker model assessment including hs-CYFRA 21-1, radiomics, and Mayo score
Follow-up
Participants are monitored for safety and effectiveness after biomarker assessment
What Are the Treatments Tested in This Trial?
Interventions
- Blood collection
- Chest Computed Tomography
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt-Ingram Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
A Combined Biomarker Model for Risk Stratification of ...
Indeterminate Pulmonary Nodules. A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility ...
Integrated Biomarkers for Pulmonary Nodules
The combined biomarker model (CBM) integrated the Mayo risk score, hs-CYFRA 21-1, and radiomic score through a logistic regression model ...
Improving lung cancer diagnosis with cancer, fungal, and ...
The combination biomarker model including the Mayo Clinic model score, histoplasmosis antibody levels, radiomics, and hsCYFRA 21-1 level showed improved ...
Integrated Biomarkers for the Management of ...
Patients with indeterminate pulmonary nodules (IPNs) at risk of cancer undergo high rates of invasive, costly, and morbid procedures.
Clinical utility of an artificial intelligence radiomics-based tool ...
Clinical utility data on pulmonary nodule (PN) risk stratification biomarkers are lacking. We aimed to determine the incremental predictive ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.