A New Pathway With BronchOscopic or Oesophageal Ultrasound for Lung Cancer Diagnosis and STaging (BOOST)

Study Overview
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Brief Summary
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In the UK, staging of lung cancer is time consuming (taking on average more than 3 weeks), costly and inaccurate in up to 20% of cases. The investigators wish to determine whether using the newer techniques of endobronchial ultrasound (EBUS) and endoscopic ultrasound (EUS) improves lung cancer staging. The investigators' hypothesis is that EUS (endoscopic ultrasound) or EBUS (endobronchial ultrasound guided transbronchial needle aspirate) as a first test after CT scan in the diagnosis and staging of lung cancer will result in a reduction in the time from first outpatient appointment to treatment decision, a reduction in the total number of scans and investigative operations, fewer outpatient attendances and a reduction in healthcare costs.

Official Title
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A Randomized Controlled Trial of Endobronchial or Endoscopic Ultrasound as a First Test in the Diagnosis and Staging of Lung Cancer

Conditions
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Bronchogenic Carcinoma

Intervention / Treatment
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* Procedure: Endobronchial or Endoscopic Ultrasound
* Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients suspected of lung cancer on CT scan Written informed consent Able to tolerate bronchoscopy and thoracic surgery Exclusion Criteria: Evidence of severe or uncontrolled systemic disease that makes it undesirable for the patient to participate in the trial Any disorder making reliable informed consent impossible Patients with extra-thoracic disease, supraclavicular lymphadenopathy or pleural effusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>Control arm: Current practice for diagnosing and staging lung cancer. Most patients with intra-thoracic disease suspected of lung cancer will undergo bronchoscopy (or CT guided biopsy), PET scan and possibly mediastinoscopy. | Procedure: Bronchoscopy, CT-guided biopsy, PET scan, Mediastinoscopy<br>* Investigations will be determined by the multi-disciplinary team responsible for the patient<br>|
| Experimental: A<br>Active arm: A new pathway for the diagnosis and staging of lung cancer with endobronchial (EBUS) or endoscopic ultrasound (EUS) as a first test. If EBUS or EUS is negative the patient will have PET scan +/- mediastinoscopy. | Procedure: Endobronchial or Endoscopic Ultrasound<br>* Patients with anterior mediastinal or subcarinal disease will undergo EBUS. Patients with posterior, subcarinal or AP window disease will undergo EUS. Patients with no mediastinal disease on CT scan will undergo EBUS.<br>* Other names: EBUS: Olympus Keymed BF-UC260F-OL8;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from first outpatient appointment to decision to treat |  | 1 - 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The healthcare costs for diagnosing and staging lung cancer |  | End of study | 
| The number of tests and outpatient visits a patient requires to be diagnosed and staged with lung cancer |  | 1 - 3 months | 
| The proportion of lung cancer patients that are diagnosed and staged with a single test after CT scan |  | 1 - 3 months | 
| The time from first outpatient appointment to treatment |  | 1 - 3 months | 
| The number of futile thoracotomies |  | 1 - 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung, Cancer, Staging, Endobronchial, Ultrasound, Endoscopic