Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Canc… (NCT06440174) | Clinical Trial Compass
RecruitingNot Applicable
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)
United Kingdom160 participantsStarted 2024-06-27
Plain-language summary
This is an observational trial that will look at patients undergoing endoscopic ultrasound (EUS) in patients with oesophageal cancer and to determine the proportion of cases in which EUS changes disease management in these patients.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.
✓. Referred for EUS examination as part of standard of care investigations.
✓. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)
✓. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy)
✓. Prior staging with CT and PET-CT
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Clinical staging of T1-T4, N0-N3, M0 disease
✓. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type
Exclusion criteria
✕. Recurrent or residual disease
✕0. Distant metastatic disease detected before EUS.
✕1. Previous oesophagectomy or oesophageal radiotherapy
✕2. Unable to undergo EUS examination.
✕3. Concurrent malignancy e.g., second primary tumour
✕
What they're measuring
1
Number of patients who change treatment management
Timeframe: this decision will be made at baseline.
Trial details
NCT IDNCT06440174
SponsorUniversity Hospital Southampton NHS Foundation Trust