Health TrialsbyHealthPanel

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

ConditionLung Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt-Ingram Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Lesions on PET or CT concerning for primary or metastatic malignancy that are amenable to biopsy by linear EBUS

Malignant cells present on rapid on-site cytological evaluation (ROSE)

Disqualifiers

Patient is known to be less than 18 years old

Patient is known to be pregnant

Patient is known to be a prisoner

Operator deems lesion is not safe to biopsy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endobronchial ultrasound with transbronchial needle aspiration

    Procedure/Surgery

    Participants will undergo Endobronchial ultrasound with transbronchial needle aspiration

  • Bronchoscopy

    Procedure/Surgery

    Participants will undergo Bronchoscopy

  • Cryobiopsy

    Procedure/Surgery

    Participants will undergo Cryobiopsy

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: EBUS-TBNA GroupActive comparator 2 interventions
Group B: Transbronchial Mediastinal Cryobiopsy GroupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Proportion of samples sufficient for next-generation sequencing testing

Comparison of samples between arms that meet sufficiency criteria for NGS

Time frame
Up to 12 months

Secondary outcomes

1

Proportion of samples with adequate PD-1 / PD-L1 immunohistochemical staining

Comparison of samples between arms that meet PD-1/PD-L1 adequacy

Time frame
Up to 12 months
2

Proportion of samples that are adequate for complete NGS library sequencing

Comparison of samples between arms that meet sufficiency criteria and then are adequate for complete NGS library sequencing

Time frame
Up to 12 months
3

Estimated total number of tumor cells per H&E-stained slide

Comparison of samples between arms of estimated tumor cells per H\&E-stained field

Time frame
Up to 12 Months
4

Histological disease subtyping

Comparison of samples between arms for subtypes of lung malignancies (primary or metastatic)

Time frame
Up to 12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt-Ingram Cancer Center

Lead sponsor

Northwestern Medicine

Collaborator

Johns Hopkins University

Collaborator

Duke University

Collaborator

Medical University of South Carolina

Collaborator

Virginia Commonwealth University

Collaborator

Source ClinicalTrials.gov
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