The SEQUENCE Trial

Conditions

• Pulmonary Nodules

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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

Study Details

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.

Key Dates

First listed

Nov 6, 2024

Start date

Nov 10, 2024

Status verified

Aug 2026

Primary completion

Aug 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

320 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Active Comparator: Linear EBUS First
  Patients will undergo a mediastinal lymph node evaluation with EBUS first, followed by biopsy followed by robotic-assisted bronchoscopy
• Active Comparator: Robotic-assisted bronchoscopy first
  Patients will undergo a robotic-assisted bronchoscopy first, followed by a mediastinal lymph node evaluation with EBUS second

Primary Outcome Measure

Number of participants who received a diagnosis as a result of the procedure [ Time Frame: This will be assessed 30 days after the procedure in a study visit that our teams conduct, it will not include the patient ]

Central Contacts

• Chris Kapp Assistant professor of medicine, MD
  312-695-3800
  [email protected]

Locations (5)

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