A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Description

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.

Conditions

Pulmonary Nodule

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Study Overview

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Study Details

Study overview

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.

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules A Multicenter Prospective Observational Pilot Study

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Condition
Pulmonary Nodule
Intervention / Treatment

-

Contacts and Locations

Aurora

Rocky Mountain Regional VA Medical Center, Aurora, Colorado, United States, 80045

Aurora

University of Colorado, Aurora, Colorado, United States, 80045

Nashville

Vanderbilt University/Ingram Cancer Center, Nashville, Tennessee, United States, 37203

Nashville

VA Tennessee Valley Healthcare Center, Nashville, Tennessee, United States, 37212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Vanderbilt-Ingram Cancer Center,

Eric Grogan, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University/Ingram Cancer Center

Study Record Dates

2029-03-31