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Introducing a non-endoscopic diagnostic test into the clinical pathway to identify high-risk patients with Barrett's oesophagus

Project DELTA - integrateD diagnostic solution for EarLy deTection of oesophageal cAncer

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN91655550
Enrollment
3000
Registered
2020-06-30
Start date
2020-07-01
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oesophageal cancer Cancer Malignant neoplasm of oesophagus

Interventions

The work is divided into four work packages with the following specific aims: 1. Work package 1 - Mine electronic health records, including drug prescription databases and endoscopy d

Sponsors

University of Cambridge
Lead Sponsor
Cambridge University Hospitals NHS Foundation Trust
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female 2. Primary care: aged 50 and over 3. With repeat prescription for acid-suppressant medication or with referral to dyspepsia service for investigation of upper GI symptoms 4. During COVID 2WW and urgent referrals will also be considered provided dysphagia is not severe to the extent that they cannot swallow a tablet

Exclusion criteria

Exclusion criteria: 1. Primary care: recorded regular prescriptions of NSAIDs 2. Primary care/dyspepsia patients: recorded diagnosis of a current or previous oro-pharynx, oesophageal or gastro-oesophageal tumour, or recorded BE 3. Primary care: received prior surgical intervention to the oesophagus 4. Difficulty in swallowing due to a known cerebrovascular accident or neurological disorder 5. Recorded oesophageal varices, cirrhosis of the liver 6. Unable to temporarily discontinue anti-thrombotic medication prior to procedure (in line with manufacturer’s guidance) 7. Lacking capacity

Design outcomes

Primary

MeasureTime frame
The feasibility and practical implementation steps of introducing CytospongeTM - TFF3 as a triage test for endoscopy to identify Barrett’s oesophagus, early cancer and other oesophageal conditions, assessed by the uptake of the Cytosponge when offered by a GP

Secondary

MeasureTime frame
1. Patient experience assessed using questionnaires after the Cytosponge procedure 2. Data to inform the development of an App collected using focus groups and interviews after the Cytosponge procedure 3. Barriers and facilitators among patients assessed using questionnaires and interviews after the Cytosponge procedure

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 19, 2026