A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
NCT ID: NCT06074133
Last Updated: 2025-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-03-07
2029-03-31
Brief Summary
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Detailed Description
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* To obtain the combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score in a prospective observational trial and estimate potential clinical utility compared to the Mayo Model.
* To establish standard operating procedures (SOPs) and protocols in a prospective observational trial in anticipation of a future randomized control trial. These include the REDCAP data input protocols, the radiomic protocols, blood draws in the CLIA environment, and estimating the CBM score in a time reasonable for clinical practice (\< 2 weeks).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Indeterminate Pulmonary Nodules
A combined biomarker model (hs-CYFRA 21-1, radiomics, Mayo) score will be obtained to estimate potential clinical utility compared to the Mayo Model.
Blood collection
Undergo blood draw
Chest Computed Tomography
Undergo standard of care chest Computed Tomography
Interventions
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Blood collection
Undergo blood draw
Chest Computed Tomography
Undergo standard of care chest Computed Tomography
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Eric Grogan
Professor of Thoracic Surgery & Medicine
Principal Investigators
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Eric Grogan, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center
Locations
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Rocky Mountain Regional VA Medical Center
Aurora, Colorado, United States
University of Colorado
Aurora, Colorado, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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NCI-2023-05725
Identifier Type: REGISTRY
Identifier Source: secondary_id
VICC-EDTHO23230
Identifier Type: -
Identifier Source: org_study_id
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