CompletedObservational

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

When patients have a camera test of the bowel (an endoscopy), doctors often take tiny tissue samples, called biopsies, to check for conditions such as bowel cancer or Crohn's disease. Around a third of these samples turn out to be completely healthy. However, specialist doctors (pathologists) must still examine every slide under a microscope, which takes significant time. The COBIx study tests a new computer tool that uses artificial intelligence to scan digital pictures of bowel biopsies. The software aims to confirm normal samples automatically and quickly flag urgent, abnormal cases so doctors can review them first. The study looks at around 10,000 routine NHS samples across 11 hospital trusts in England and Scotland. Because the research only uses existing biopsy slides and hospital records, patients do not need to attend extra appointments, take new medicines, or undergo extra procedures.

At a glance

Status

Completed

Sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Enrolment target

10,000

Start

01 Dec 2023

Estimated completion

30 Sep 2025

Colon and rectal endoscopic biopsy

What is this study about?

Conditions affecting the large bowel, such as bowel cancer, ulcerative colitis, and Crohn's disease, are diagnosed by examining small tissue samples known as biopsies. These are collected during routine camera examinations of the bowel. Hospital laboratories receive thousands of these samples every week. Even though around 30% to 40% of biopsies show no sign of disease, an expert doctor called a pathologist must carefully inspect every single one under a microscope. This heavy workload can sometimes lead to delays for patients waiting for their results.

Many NHS laboratories now have the technology to scan glass microscope slides into high-resolution digital images on a computer. The COBIx study evaluates an intelligent computer program designed to analyse these digital pictures. By scanning the patterns in the tissue, the tool aims to safely recognise healthy biopsies on its own. At the same time, it can highlight samples that show serious disease so specialists can prioritise them for urgent review.

Over three years, researchers will test COBIx across 11 NHS hospital trusts in England and Scotland using approximately 10,000 routine bowel samples. They will compare the computer's findings directly against the diagnoses made by NHS pathologists. If successful, this technology could help laboratories work through samples more quickly, cut waiting times, and help patients start necessary treatments sooner.

Key takeaways

COBIx is an artificial intelligence computer tool designed to analyse digital pictures of bowel biopsies.
The study tests whether the tool can safely identify healthy samples and quickly flag serious illnesses.
Around 10,000 routine NHS tissue samples from 11 hospital trusts across England and Scotland are being examined.
There are no extra hospital visits, medications, or blood tests required from patients.
All patient information is kept confidential and anonymised in line with NHS data protection laws.

Who may be eligible?

This study focuses on tissue samples taken from adults aged 18 and over who have had a biopsy of the large bowel (the colon or rectum) during a standard camera examination.

The study cannot include biopsies from children or teenagers under 18 years old. It also excludes samples taken from other parts of the digestive tract (such as the stomach or small bowel), as well as larger sections of tissue removed during major bowel surgery.

Patients do not need to sign up or apply directly. NHS hospital staff identify suitable samples that have already been collected for routine care. They will also check your NHS research preferences to make sure your samples are only included if you have agreed to let your tissue be used for medical research.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You are aged 18 or older.
You had a biopsy taken from your large bowel (colon or rectum) during a camera test.
Your biopsy was carried out at a participating NHS hospital.
You have not chosen to opt out of NHS medical research.
Your sample is a small biopsy, not tissue from major bowel surgery or from the small intestine.

Answer every question to see your result.

What does participation involve?

Taking part in this study does not require any clinic visits, extra tests, changes to your diet, or new medications. Your routine medical care will continue exactly as planned by your healthcare team.

The study simply uses biopsy samples and medical information that your hospital has already collected. Hospital staff will securely scan your biopsy slides into digital images, remove all identifying personal details to keep them anonymous, and upload them to a secure research system. The research team will also review relevant routine health records, such as your age, treatments, and test results, via restricted, password-protected systems. The project runs until June 2026, and because there are no direct tests or appointments for you, there is no personal follow-up required.

Potential risks and benefits

Because the study only uses tissue samples and information that have already been collected, there are no physical risks, side effects, or discomfort involved. Taking part will not directly change your personal test results or current treatment plan, but it could help future NHS patients receive quicker bowel diagnoses. All records are strictly protected and anonymised by your NHS care team to keep your information secure. You always have the right to opt out of having your health records or tissue used in research, and choosing to do so will never affect the standard of care you receive.

Locations (9)

University Hospital Southampton NHS Foundation Trust
City only
Southampton, England
Oxford University Hospitals NHS Foundation Trust
City only
Oxford, England
Cambridge University Hospitals NHS Foundation Trust
City only
Cambridge, England
Greater Glasgow and Clyde
City only
Glasgow, Scotland
Darlington Memorial Hospital
Approximate
Darlington, England
North Tees and Hartlepool NHS Foundation Trust
Unverified
Hartlepool, England
University Hospitals Coventry and Warwickshire NHS Trust
Unverified
Coventry, England
Sheffield Teaching Hospitals NHS Foundation Trust
Unverified
Sheffield, England
University Hospitals Birmingham NHS Foundation Trust
Unverified
Birmingham, England

Common questions

Do I have to go to any extra hospital appointments?

No. The study only uses biopsy samples and health information that have already been collected as part of your normal NHS care.

Will this study affect the results of my biopsy?

No. Your tissue sample will still be fully checked and reported by NHS specialist doctors in the usual way. The computer tool is being tested alongside regular care, not instead of it.

How does the COBIx computer tool work?

COBIx looks at digital images of tissue slides and uses smart software to detect patterns. It learns to tell the difference between healthy tissue and signs of disease, such as inflammation or cancer.

Is my personal data safe?

Yes. Before any image or detail is shared with researchers, your personal information is anonymised by NHS hospital staff. Data is stored on secure, protected servers following strict NHS privacy rules.

What if I do not want my samples used in this study?

You can register your choice via the NHS National Data Opt-Out service or speak to your hospital care team. If you opt out, your samples and records will not be used, and your care will not be affected in any way.

How to find out more

Rachel Flowers

cobix@uhcw.nhs.uk +44 (0)2476 968650 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.