Examining how endoscopic ultrasound affects treatment decisions in oesophageal cancer
Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE): a Multi-methods Study
This study looks at how using endoscopic ultrasound can change treatment plans for patients with oesophageal cancer to see if it helps them get better care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 14 sites (Abercynon and 13 other locations) |
| Trial ID | NCT06440174 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of endoscopic ultrasound (EUS) in managing patients with oesophageal cancer. It aims to determine how often EUS alters treatment decisions after initial staging with CT and PET-CT. The study includes both quantitative and qualitative components, assessing the frequency of changes in management and exploring clinician and patient perspectives on EUS's utility. The trial will recruit patients with potentially curable disease who are fit for EUS as part of their standard care.
Who should consider this trial
Good fit: Ideal candidates are patients aged 16 or older with a first diagnosis of biopsy-confirmed oesophageal cancer who are deemed potentially curable.
Not a fit: Patients with recurrent or metastatic disease, or those unable to undergo EUS examination, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment decision-making for patients with oesophageal cancer, potentially improving outcomes.
How similar studies have performed: While the use of EUS in oesophageal cancer is established, this study's specific focus on its impact on treatment decisions is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer. 2. Referred for EUS examination as part of standard of care investigations. 3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III) 4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +/- neoadjuvant therapy, or definitive chemoradiotherapy) 5. Prior staging with CT and PET-CT 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 7. Clinical staging of T1-T4, N0-N3, M0 disease 8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type Exclusion Criteria: 9. Recurrent or residual disease 10. Distant metastatic disease detected before EUS. 11. Previous oesophagectomy or oesophageal radiotherapy 12. Unable to undergo EUS examination. 13. Concurrent malignancy e.g., second primary tumour 14. Other histopathological cell type
Where this trial is running
Abercynon and 13 other locations
- Cwm Taf UHB — Abercynon, United Kingdom (Recruiting)
- Royal Bournemouth Hospital — Bournemouth, United Kingdom (Terminated)
- Cambridge University NHS Foundation Trust — Cambridge, United Kingdom (Recruiting)
- Cardiff and Vale UHB — Cardiff, United Kingdom (Recruiting)
- Velindre University NHS Trust — Cardiff, United Kingdom (Recruiting)
- Glasgow Royal Infirmary — Glasgow, United Kingdom (Recruiting)
- Castle Hill Hospital — Hull, United Kingdom (Recruiting)
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust — London, United Kingdom (Recruiting)
- Queen's Medical Centre, Nottingham — Nottingham, United Kingdom (Recruiting)
- Salford Royal Hospital — Salford, United Kingdom (Recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Recruiting)
- Singleton Hospital, Swansea — Swansea, United Kingdom (Recruiting)
- Royal Cornwall Hospital — Truro, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Kieran Foley — Chief Investigator, based at Velindre University NHS Trust
- Study coordinator: Ben Lindfield
- Email: value@soton.ac.uk
- Phone: 023 8120 5154
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.