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Trial Title:
A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules
NCT ID:
NCT06074133
Condition:
Pulmonary Nodule
Conditions: Official terms:
Multiple Pulmonary Nodules
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Blood collection
Description:
Undergo blood draw
Arm group label:
Indeterminate Pulmonary Nodules
Intervention type:
Procedure
Intervention name:
Chest Computed Tomography
Description:
Undergo standard of care chest Computed Tomography
Arm group label:
Indeterminate Pulmonary Nodules
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.
Detailed description:
Objectives:
- 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).
Criteria for eligibility:
Study pop:
Patients recruited from pulmonary or thoracic clinics that have indeterminate pulmonary
nodules
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rocky Mountain Regional VA Medical Center
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vanderbilt-Ingram Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Melissa New, MD
Email:
Principal Investigator
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Anna 'Baron, PhD
Email:
Principal Investigator
Facility:
Name:
Vanderbilt University/Ingram Cancer Center
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanderbilt-Ingram Service Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Eric Grogan, MD
Email:
Principal Investigator
Facility:
Name:
VA Tennessee Valley Healthcare Center
Address:
City:
Nashville
Zip:
37212
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Vanderbilt-Ingram Services for Timely Access
Phone:
800-811-8480
Email:
cip@vumc.org
Investigator:
Last name:
Eric Grogan, MD
Email:
Principal Investigator
Start date:
March 7, 2024
Completion date:
March 31, 2029
Lead sponsor:
Agency:
Vanderbilt-Ingram Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Vanderbilt-Ingram Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06074133
