RECRUITING

EBUS-TBNA vs Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Conditions

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 multi-center clinical trial evaluating the effect of transbronchial mediastinal cryobiopsy for its ability to improve the likelihood of obtaining tissue sufficient for molecular analysis. Patients in outpatient clinics or pre-operative holding areas planning to undergo a bronchoscopic biopsy of a suspected malignant lesion (peripheral or mediastinal) for initial diagnosis, staging, or tissue acquisition for molecular analysis will be considered for enrollment and consented. Patients will only be enrolled if intraoperative ROSE suggests malignancy. Patients will be randomized to continue with the operator's initial EBUS-TBNA needle or switch to a cryoprobe to perform a sampling.

Official Title

A Multicenter Randomized Trial of EBUS-TBNA Versus Transbronchial Mediastinal Cryobiopsy for Adequacy of Next Generation Sequencing

Quick Facts

Study Start:2024-09-13
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06105801

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS
  2. * Malignant cells present on rapid on-site cytological evaluation (ROSE)
  1. * Patient is known to be less than 18 years old
  2. * Patient is known to be pregnant
  3. * Patient is known to be a prisoner
  4. * Operator deems lesion is not safe to biopsy

Contacts and Locations

Study Contact

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

Principal Investigator

Fabien Maldonado, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University/Ingram Cancer Center

Study Locations (Sites)

Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt-Ingram Cancer Center

  • Fabien Maldonado, 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 Date2024-09-13
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2024-09-13
Study Completion Date2028-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Lung Cancer