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COBIx: Multi-site validation study of the COBIx reporting tool

COBIx: Multi-site validation study of the Colon and Rectal Endoscopic Biopsy (COBIx) reporting tool

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN96000018
Enrollment
10000
Registered
2024-02-20
Start date
2023-12-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Colon and rectal endoscopic biopsy Digestive System

Interventions

Current interventions as of 02/05/2025: The study aims to recruit 10,000 patient samples from adults across 10 separate centres in the UK. All of the Haematoxylin and Eosin (H&E) stained slides (app

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 120 Years

Inclusion criteria

Inclusion criteria: Large bowel biopsies taken from adult patients at an endoscopic examination

Exclusion criteria

Exclusion criteria: 1. All other types of GI biopsies e.g. small bowel 2. Other types of large bowel specimens e.g. resections 3. Biopsies from children and young persons (under 18 years)

Design outcomes

Primary

MeasureTime frame
The effectiveness of the COBIX algorithm compared with the original pathologist diagnosis (e.g. sensitivity, specificity, AUC-ROC, false negative rate, false positive rate, PPV, NPV) measured using a range of statistical measures at one timepoint

Secondary

MeasureTime frame
The effectiveness of the COBIX algorithm at separating samples into different diagnostic categories compared with the original pathologist diagnosis measured using a range of statistical measures at one timepoint

Countries

England, Scotland, United Kingdom

Contacts

Public ContactRachel Flowers
cobix@uhcw.nhs.uk+44 (0)2476 968650

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026