Actively Recruiting
The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia
Led by University of Cambridge · Updated on 2024-05-08
147
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
Sponsors
U
University of Cambridge
Lead Sponsor
U
University of Nottingham
Collaborating Sponsor
AI-Summary
What this Trial Is About
This prospective cohort study aims to assess the utility of a panel of molecular biomarkers for predicting the risk of relapse of Barrett's Oesophagus after endoscopic treatment of early oesophageal neoplasia with RadioFrequency Ablation (RFA). Patients who received endoscopic treatment of early oesophageal neoplasia with RFA and achieved endoscopic remission will be recruited. During the surveillance visits patients will receive a Cytosponge test followed by an endoscopy with Narrow Band Imaging (NBI) magnification and biopsies. Patients will receive an endoscopy every 6 months and Cytosponge every 12 months for at least 2 years. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples. After 2 years of intensive endoscopic follow up, patients will be prospectively tracked for up to 3 years. The investigators will also evaluate: * The risk of progression to dysplasia or oesophageal intestinal metaplasia (IM) in patients with IM at the GOJ post RFA in the absence of retreatment * the diagnostic accuracy of NBI for IM/dysplasia at the GOJ .
CONDITIONS
Official Title
The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Previous RadioFrequency Ablation (RFA) for dysplastic Barrett's Oesophagus or following endoscopic mucosal resection for related neoplasia
- No definite endoscopic evidence of Barrett's Oesophagus defined as at least 1cm tongue of columnar oesophagus or islands larger than 5mm
- No histological evidence of oesophageal intestinal metaplasia including buried Barrett's Oesophagus at first post-RFA follow-up; intestinal metaplasia at the gastro-oesophageal junction is allowed
- No evidence of suspicious lesions with dysplasia at the gastro-oesophageal junction
You will not qualify if you...
- Evidence of Barrett's Oesophagus requiring additional RadioFrequency Ablation
- Use of anticoagulant or antiplatelet therapy for high-risk conditions where stopping treatment is not recommended
- Diagnosis of oro-pharynx, oesophageal, or gastro-oesophageal tumor of T2 staging or higher, or symptoms of swallowing difficulty
- Presence of oesophageal varices, strictures, or need for oesophageal dilation
- Myocardial infarction or any cardiac event within the past six months
- Previous ablative treatment other than RadioFrequency Ablation such as photodynamic therapy, argon plasma coagulation, or cryotherapy
- Unable to provide informed consent
- Under 18 years of age
- Pregnancy generally avoided due to endoscopy risks, though not an absolute contraindication; pregnancy status not recorded in trial
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Trial Site Locations
Total: 1 location
1
MRC Cancer Unit
Cambridge, United Kingdom, CB2 0XZ
Actively Recruiting
Research Team
M
Massimiliano Di Pietro, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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