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

Study acronym: FROSTBITE-3
StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Phase: Phase 3 to Phase 4 Collaborators: 3 to 5v7 Show 1 more changeShow less
    • Collaborators: 3 to 5

    See this version in full on ClinicalTrials.gov ↗

  2. Collaborators expanded, about 7 wordsv6 See this version in full on ClinicalTrials.gov ↗
  3. Start date changed from estimate of Oct 31, 2024 to Sep 13, 2024 Eligibility criteria expanded, about 3 wordsv5 Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Site details revised · Eligibility criteria shortened, about 2 words · Study description expanded, about 2 words · 1 morev4 Show 4 more changesShow less
    • Site details revised
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 2 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Primary completion date: Feb 1, 2027 to Oct 31, 2027 Start date: Feb 28, 2024 to Oct 31, 2024 · Completion date: Feb 1, 2028 to Oct 31, 2028v3 Show 2 more changesShow less
    • Start date: Feb 28, 2024 to Oct 31, 2024
    • Completion date: Feb 1, 2028 to Oct 31, 2028
  6. Start date: Nov 30, 2023 to Feb 28, 2024 Primary completion date: Dec 1, 2026 to Feb 1, 2027 · Completion date: Dec 1, 2027 to Feb 1, 2028v2 Show 2 more changesShow less
    • Primary completion date: Dec 1, 2026 to Feb 1, 2027
    • Completion date: Dec 1, 2027 to Feb 1, 2028
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06105801
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: Northwestern Medicine, Johns Hopkins University, Duke University, Medical University of South Carolina, Virginia Commonwealth University
Conditions Lung Cancer
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov