The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia

  • STATUS
    Recruiting
  • End date
    Dec 1, 2024
  • participants needed
    147
  • sponsor
    University of Cambridge
Updated on 26 January 2021

Summary

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 .

Description

The panel of predetermined molecular biomarkers includes:

  1. IM-SCORE - a score quantifying the extent of intestinal metaplasia at GOJ, which uses a 4-tier system based on the number of glands and the number of biopsies with features of IM. The score has been developed in a pilot study (manuscript under submission) and will be validated in this study
  2. Methylation markers- assessed by a PCR-based method (Methylight) on Cytosponge samples.
  3. P53 status.
  4. TFF3 protein expression.

Details
Condition BARRETT'S ESOPHAGUS, BARRETT'S ESOPHAGUS
Treatment Cytosponge test, Assessment of the panel of molecular biomarkers: IM-SCORE, TFF3 protein expression, methylation panel, p53 mutation, Oesophagogastroduodenoscopy
Clinical Study IdentifierNCT04155242
SponsorUniversity of Cambridge
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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