The SEQUENCE Trial

NCT06676956 | Recruiting FDA Device

• 1 other identifier: STU00222248 (IRB)
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 5

Brief Summary

This study will randomize participants undergoing a bronchoscopic biopsy of a peripheral pulmonary nodule for their standard of care to receive robotic-assisted bronchoscopy (RaB) and then staging linear endobronchial ultrasounnd (EBUS) OR staging linear EBUS first, followed by RaB. The goal of this study is to set the standard for optimizing the sequence of bronchoscopic procedures in patients at risk for early-stage malignancy.

Conditions

Pulmonary Nodules

Outcome Measures

Primary Outcomes (1)

• Number of participants who received a diagnosis as a result of the procedure

  This will be an outcome measure that is positive or negative based on whether a diagnosis was achieved during the procedure

  This will be assessed 30 days after the procedure in a study visit that our teams conduct, it will not include the patient

Secondary Outcomes (1)

• Severity of atelectasis during the procedure

  This will be assessed day of procedure and recorded

Study Arms (2)

Linear EBUS First

ACTIVE COMPARATOR

Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy

Diagnostic Test: Linear EBUS first

Robotic-assisted bronchoscopy first

ACTIVE COMPARATOR

Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Diagnostic Test: Robotic-assisted bronchoscopy first

Interventions

Linear EBUS first DIAGNOSTIC_TEST

Patients randomized to this arm will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy.

Linear EBUS First

Robotic-assisted bronchoscopy first DIAGNOSTIC_TEST

Patients randomized to this arm will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Robotic-assisted bronchoscopy first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral Pulmonary Nodule undergoing a robotic-assisted bronchoscopy

You may not qualify if:

• lymph nodes that are enlarged or PET avid on CT prior to procedure

Sponsors & Collaborators

• Northwestern University: lead
• Johns Hopkins University: collaborator
• University of Michigan: collaborator
• University of California, Davis: collaborator
• University of California, San Diego: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (5)

University of California, Davis

Sacramento, California, 95817, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Chris Kapp Assistant professor of medicine, MD

CONTACT

312-695-3800; christopher.kapp@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 6, 2024
• Study Start: November 10, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 10/28/24 - two years
• Access Criteria: Only study personnel.

Locations

US (5)