The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia (PROBAN)
Barrett's Oesophagus
About this trial
This is an interventional diagnostic trial for Barrett's Oesophagus focused on measuring Barrett's oesophagus, Radiofrequency ablation, Early Oesophageal Neoplasia
Eligibility Criteria
Inclusion Criteria
- Previous RFA for dysplastic BE or following EMR for BE-related neoplasia
- No definite endoscopic evidence of BE defined as at least 1cm tongue of columnar oesophagus or oesophageal BE islands larger than 5mm.
- No histological evidence of oesophageal IM including buried BE at first post RFA follow up. GOJ IM is allowed
- No evidence of suspicious lesions with dysplasia at the GOJ.
Exclusion criteria
- Evidence of BE requiring additional RFA
- Anticoagulant or antiplatelet therapy for high risk conditions, whereby discontinuation of the treatment is not recommended.
- Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia,
- Oesophageal varices, stricture or requiring dilatation of the oesophagus
- Individuals who have had a myocardial infarction or any cardiac event less than six months ago
- Patients whose primary previous ablative treatment was different from RFA, such as Photodynamic therapy (PDT), APC or Cryotherapy
- Participants who are unable to provide informed consent.
- Participants under age 18.
- Endoscopy is generally avoided in pregnant women and therefore it is unlikely that any pregnant women will be included although pregnancy would not be an absolute contraindication. Pregnancy/ pregnancy test will not be recorded as part of the trial.
Sites / Locations
- MRC Cancer UnitRecruiting
Arms of the Study
Arm 1
Experimental
Study group
As part of the post RFA treatment follow up patients will receive a Cytosponge test followed by an endoscopy with NBI magnification and biopsies. Four endoscopies will be performed during 2 years of active follow up together with up to 2 Cytosponge procedures. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples obtained during the examinations will be assessed. Patients will be then followed up for up to 3 years with standard endoscopy to assess for relapse of Barrett's oesophagus/IM/dysplasia.