RECRUITING

A Combined Biomarker Model for Risk Stratification of Indeterminate Pulmonary Nodules

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-07
Study Completion:2029-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06074133

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.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults \> 21 y/o
  2. * IPNs 8-30mm referred for evaluation Figure 4. AUC and reclassification of Combined Biomarker Model
  3. * Intermediate risk IPN defined as 10-70% risk after applying Mayo risk predictor model
  4. * Solid nodules or part-solid nodules with solid component \>=8mm
  5. * CT scan with nodule of concern performed within 60 days of enrollment
  1. * Currently on therapy for any cancer
  2. * History of primary lung cancer within the last 5 years
  3. * Multiple nodules highly suspicious for metastatic disease
  4. * Other malignancy within the last 2 year - Excluding skin cancer other than melanoma
  5. * Pregnant women
  6. * Prisoners
  7. * Inability to provide informed consent
  8. * Serologic evidence of active fungal infection

Contacts and Locations

Study Contact

Vanderbilt-Ingram Services for Timely Access
CONTACT
800-811-8480
cip@vumc.org

Principal Investigator

Eric Grogan, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center

Study Locations (Sites)

Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045
United States
University of Colorado
Aurora, Colorado, 80045
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37203
United States
VA Tennessee Valley Healthcare Center
Nashville, Tennessee, 37212
United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-07
Study Completion Date2029-03-31

Study Record Updates

Study Start Date2024-03-07
Study Completion Date2029-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Pulmonary Nodule