Using biomarkers to manage Barrett's Oesophagus after radiofrequency ablation

Prospective Study on the Use of Biomarkers to Guide Management of Patients Treated With Radiofrequency Ablation for Early Oesophageal Neoplasia

This study is testing if certain biological markers can help doctors predict the risk of Barrett's Oesophagus coming back in patients who have had treatment with radiofrequency ablation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 147 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Cambridge (Academic / other)
• Locations: 1 site (Cambridge)
• Trial ID: NCT04155242 on ClinicalTrials.gov

What this trial studies

This prospective cohort study evaluates the effectiveness of a panel of molecular biomarkers in predicting the risk of relapse in patients with Barrett's Oesophagus who have undergone radiofrequency ablation for early oesophageal neoplasia. Participants will receive regular surveillance through Cytosponge tests and endoscopies over a period of at least two years, during which various biomarkers will be assessed. The study aims to identify patients at higher risk of disease progression and improve management strategies based on these findings.

Who should consider this trial

Good fit: Ideal candidates include individuals who have previously undergone radiofrequency ablation for dysplastic Barrett's Oesophagus and currently show no evidence of disease.

Not a fit: Patients with ongoing Barrett's Oesophagus requiring further treatment or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective management of Barrett's Oesophagus, potentially reducing the risk of cancer progression.

How similar studies have performed: Other studies have shown promise in using biomarkers for cancer risk assessment, suggesting that this approach may be beneficial, although this specific methodology is relatively novel.

Eligibility criteria

Inclusion Criteria

1. Previous RFA for dysplastic BE or following EMR for BE-related neoplasia
2. No definite endoscopic evidence of BE defined as at least 1cm tongue of columnar oesophagus or oesophageal BE islands larger than 5mm.
3. No histological evidence of oesophageal IM including buried BE at first post RFA follow up. GOJ IM is allowed
4. No evidence of suspicious lesions with dysplasia at the GOJ.

Exclusion criteria

1. Evidence of BE requiring additional RFA
2. Anticoagulant or antiplatelet therapy for high risk conditions, whereby discontinuation of the treatment is not recommended.
3. Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour (T2 staging and above), or symptoms of dysphagia,
4. Oesophageal varices, stricture or requiring dilatation of the oesophagus
5. Individuals who have had a myocardial infarction or any cardiac event less than six months ago
6. Patients whose primary previous ablative treatment was different from RFA, such as Photodynamic therapy (PDT), APC or Cryotherapy
7. Participants who are unable to provide informed consent.
8. Participants under age 18.
9. 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.

Where this trial is running

Cambridge

• MRC Cancer Unit — Cambridge, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Massimiliano Di Pietro, MD — MRC Cancer Unit, Hutchison-MRC Research Hon. Consultant Gastroenterologist, Addenbrooke's Hospital, Cambridge.
• Study coordinator: Massimiliano Di Pietro, MD

Conditions Barrett's Oesophagus; Barrett's oesophagus; Radiofrequency ablation; Early Oesophageal Neoplasia