ACTIVE_NOT_RECRUITING

Nodify XL2 Classifier Clinical Utility Study in Low to Moderate Risk Lung 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 study evaluates the how addition of the Nodify XL2 test result impacts the clinical management of newly identified solid lung nodules assessed as low to moderate risk of cancer.

Official Title

A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules

Quick Facts

Study Start:2020-12-18
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04171492

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:40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subject has provided informed consent to participate in the study and agrees to comply with all protocol requirements
  2. 2. Subject is \> 40 years of age at the time of the discovery of the lung nodule of concern
  3. 3. Subject's lung nodule of concern meets the following:
  4. * Was incidentally identified or detected during lung cancer screening
  5. * Is a solid nodule
  6. * Has maximal dimension of \> 8mm and \< 30mm
  7. 4. The first CT scan identifying the lung nodule of concern was performed within 60 days of subject enrollment
  8. 5. The pre-test risk of cancer as determined by the Mayo risk prediction algorithm is 65% or less
  1. 1. Nodule work-up at the time of subject enrollment indicating any prior attempted or completed diagnostic biopsy procedure or blood-based testing for the lung nodule of concern
  2. 2. Nodule of concern is part-solid or Ground Glass Opacity (GGO)
  3. 3. Prior diagnosis of lung cancer
  4. 4. Any active cancer within 5-years of nodule detection, with the exception of non-melanoma skin cancer
  5. 5. Administration of blood products (i.e. packed red blood cells, fresh frozen plasma, or platelets) within 30 days of subject enrollment
  6. 6. Concurrent participation in any unrelated clinical trial that may impact or alter the management of the subject's nodule of concern
  7. 7. Any illness or factor that will inhibit compliance with study participation

Contacts and Locations

Principal Investigator

Steven Springmeyer
PRINCIPAL_INVESTIGATOR
Biodesix, Inc.
Gerard Silvestri, MD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

University of Colorado
Aurora, Colorado, 80045
United States
Massachusetts General Hospital
Boston, Connecticut, 02114
United States
Beth Israel Deaconess
Boston, Connecticut, 02215
United States
MedStar
Washington, District of Columbia, 20010
United States
Indiana University
Indianapolis, Indiana, 46202
United States
The Johns Hopkins University
Baltimore, Maryland, 21205
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
The Washington University
Saint Louis, Missouri, 63110
United States
Mount Sinai Health System
New York, New York, 10029
United States
Northwell Health
New York, New York, 11042
United States
The University of North Carolina
Chapel Hill, North Carolina, 27599
United States
Duke University
Durham, North Carolina, 27705
United States
Southeastern Research Center
Winston-Salem, North Carolina, 27103
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University
Coulmbus, Ohio, 43210
United States
The Oregon Clinic
Portland, Oregon, 97220
United States
Ralph H Johnson VA Medical Center
Charleston, South Carolina, 29401
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Prisma Health
Greenville, South Carolina, 29605
United States
University of Texas Southwestern
Dallas, Texas, 75390
United States
University of Texas Medical Branch
Galveston, Texas, 77555
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States

Collaborators and Investigators

Sponsor: Biodesix, Inc.

  • Steven Springmeyer, PRINCIPAL_INVESTIGATOR, Biodesix, Inc.
  • Gerard Silvestri, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

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 Date2020-12-18
Study Completion Date2026-12

Study Record Updates

Study Start Date2020-12-18
Study Completion Date2026-12

Terms related to this study

Additional Relevant MeSH Terms

  • Nodule Solitary Pulmonary
  • Non-small Cell Carcinoma