Developing new tests to detect oesophageal dysplasia in patients using historic capsule sponge data

Not Applicable

• Conditions: Oesophageal dysplasia; Digestive System

• Registration Number: ISRCTN15940781
• Lead Sponsor: Cyted Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-23
• Last Update Posted: 5 August 2024
• Study Completion: 2027-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Cases:
1. 18 years old or over
2. Male or Female
3. Previously diagnosed with Barrett’s oesophagus
4. Capsule sponge test performed after 1 June 2021 with a positive p53 and/or positive atypia biomarker result
5. Endoscopic biopsy with pathology performed subsequent to capsule sponge

Controls:
1. 18 years old or over
2. Male or Female
3. Previously diagnosed with Barrett’s oesophagus
4. Capsule sponge test performed after 1 January 2022 with a negative p53 and negative atypia biomarker result
5. Endoscopic biopsy with pathology performed subsequent to capsule sponge with non-dysplastic pathology observed

Exclusion Criteria

1. Under 18 years old
2. Barrett’s diagnosis unconfirmed
3. Capsule sponge biomarker test missing p53 and atypia results
4. Missing endoscopic pathology results
5. Patient deceased

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured using patient records:<br>1. Capsule sponge biomarkers for dysplasia (p53/atypia)<br>2. Follow-up endoscopic histopathology for Barrett's oesophagus (non-dysplastic, indeterminate, low-grade, high-grade, intramucosal adenocarcinoma)<br>3. Novel whole-genome molecular targets (proprietary currently) evaluated using an algorithm to provide a probability estimation for likelihood of dysplasia/cancer.<br>

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures