Barrett?s oesophagus screening trial in a case control study

Not Applicable

Completed

• Conditions: Barrett's oesophagus; Digestive System; Barrett's oesophagus/oesophageal adenocarcinoma

• Registration Number: ISRCTN12730505
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-05
• Last Update Posted: 22 May 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1400

Inclusion Criteria

1. Any participant 18 years and above clinically fit for an endoscopy with Barrett?s oesophagus (Cases) with or without upper gastrintestinal (GI) symptoms
2. Any participant 18 years and above clinically fit for an endoscopy with upper GI symptoms of reflux or dyspepsia as an indication for endoscopy / gastroscopy (Controls)
3. Ability to provide informed consent
4. Patients who have undergone endoscopic mucosal resection (EMR) for high grade dysplasia and due for repeat endoscopy

Exclusion Criteria

1. Individuals with a diagnosis of an oro-pharynx, oesophageal or gastro-oesophageal tumour, or symptoms of dysphagia
2. Oesophageal varices, stricture or requiring dilatation of the oesophagus
3. On anticoagulation therapy / medication (warfarin, clopridogrel, heparin or tinzaparin)
4. Individuals who have had a myocardial infarction or any cardiac event less than six months ago
5. Individuals who have had a cerebrovascular event < 6 months ago where their swallowing has been affected
6. Patients who have had previous treatment such as photodynamic therapy (PDT) or radio frequency ablation (RFA)
7. Participants who are unable to provide informed consent
8. Participants under age 18
9. Participants who exclude beef from their diet as the gelatine is beef based. This can be discussed with the patient
10. 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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Performance and safety characteristics of the Cytosponge test <br>2. Effectiveness of the Cytosponge for diagnosing BE compared with endoscopy, including specificity (from controls) and sensitivity (from cases)<br>2. For patients with BE, the ability of Cytosponge biomarkers to risk stratify patients in comparison with dysplasia grade obtained from endoscopic biopsies

Secondary Outcome Measures

Name	Time	Method
1. Differential sensitivity of screening BE with dysplasia (low and high grade) compared to non-dysplastic BE<br>2. Determine the reproducibility of the Cytosponge result by repeated testing in a subset of individuals<br>3. Logistics of high-throughput sample processing and automated analysis of Cytosponge specimens for use in routine National Health Services (NHS) or other health care settings.