Status:
RECRUITING
Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Imperial College Healthcare NHS Trust
Hull University Teaching Hospitals NHS Trust
Conditions:
Oesophageal Squamous Cell Carcinoma
Oesophageal Cancer
Eligibility:
All Genders
18-90 years
Brief Summary
Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5...
Detailed Description
In this prospective multicentre case-control study, the investigators will recruit a total of 518 patients. These will be divided into the following groups: 1. Cancer group (n=259): Patients with tre...
Eligibility Criteria
Inclusion
- Participants with all the following characteristics will be eligible for inclusion in the study:
- Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.
- Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either:
- A normal upper gastrointestinal tract
- Benign upper gastrointestinal disease
Exclusion
- Participants with the following characteristics will not be eligible for inclusion in the study:
- Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC
- History of another cancer in the last five years
- Non-squamous cell oesophageal cancer
- Barrett's oesophagus (with or without dysplasia)
- Previous oesophageal or gastric resection
- Unable to provide written consent or lack capacity.
- Pregnant women
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT06169163
Start Date
December 1 2023
End Date
December 31 2026
Last Update
May 2 2025
Active Locations (13)
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1
Imperial College Healthcare NHS Trust
London, Greater London, United Kingdom, W12 0NN
2
Hull University Teaching Hospitals NHS Trust
Cottingham, Hull, United Kingdom
3
Cardiff and Vale University Health Board
Cardiff, United Kingdom
4
Velindre NHS Trust
Cardiff, United Kingdom