The Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia
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- STATUS
- Recruiting
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- End date
- Dec 1, 2024
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- participants needed
- 147
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- sponsor
- University of Cambridge
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:
- 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
- Methylation markers- assessed by a PCR-based method (Methylight) on Cytosponge samples.
- P53 status.
- 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 Identifier | NCT04155242 |
| Sponsor | University of Cambridge |
| Last Modified on | 26 January 2021 |
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