A study looking at cell changes in people with Barrett's oesophagus (TIME)

Cancer type:

Oesophageal cancer

Status:

Results

Phase:

Pilot

This study used a new type of endoscopy to find and help study cell changes. It was for people with a pre cancerous condition called Barrett’s oesophagus.

This trial was open for people to join between 2009 and 2014. The team published the results in 2014 and 2015.

More about this trial

Barrett’s oesophagus changes the normal cell lining of the food pipe (oesophagus). This means that the cells become more like cells of the stomach or small bowel. Some people with Barrett’s oesophagus may develop ulcers, narrowing of the food pipe (strictures) and very rarely cancer of the food pipe. 

Doctors regularly check your food pipe using a small camera on a thin flexible tube (endoscope) if you have Barrett’s oesophagus. This is an endoscopy.

Researchers wanted to understand more about different endoscopies. They wanted to know if they could detect cell changes that might cause Barrett's oesophagus to turn into cancer. 

In this study, they used a type of endoscopy called ETMI (Endoscopic Tri-Modal Imaging). The standard endoscope uses a white light to show up areas of abnormal tissue. ETMI has special filters to choose green and blue light to show up changes that white light can’t. ETMI includes autofluorescence imaging (AFI) which uses blue light only and Narrow Band Imaging (NBI) which used green and blue light. 

Research shows that ETMI helps doctors to see areas of the food pipe that have abnormal cells or very early cancer. It shows areas of abnormal cells that standard endoscopy can’t show.

They are also using a tiny microscope called pCLE (probe based Confocal Laser Endomicroscopy). pCLE is a special microscope that the doctor passes down the ETMI endoscope. This helps doctors see changes to cells.

In this study, researchers studied samples of tissue (biopsies Open a glossary item) taken during the endoscopy. They looked for features (tumour marker Open a glossary item) that are linked to abnormal cell changes that lead to cancer.

They hoped to develop a test to diagnose the disease more easily using this information. And to work out more accurately who is at higher risk of developing cancer.

Summary of results

The team found that using the green light filters and the pCLE microscope can identify cell changes in Barrett’s oesophagus.  

About this study
There were 55 people in this study. Everyone had an EMTI endoscopy followed by pCLE. The team took tissue samples (biopsies) from the Barrett’s oesophagus. They took samples using the blue lights (AFI) and without them. 

They looked at the cells of these samples in the lab. They wanted to find out how many showed signs of abnormal cells. They also looked at markers that show changes in the cells of Barrett’s oesophagus. These are called biomarkers. The researchers thought that they might help diagnose it. 

Results
From the 55 people the team had 194 tissue samples to look at. The team looked at the cells of these tissue samples taken from the Barrett’s oesophagus. They wanted to see how abnormal the cells were. They found that in:

  • 122 samples there were no abnormal cells 
  • 20 samples it wasn’t clear how normal the cells were
  • 24 samples the cells looked different to normal cells
  • 21 samples the cells looked very different to normal cells
  • 7 samples there were cancer cells

The team looked at the test results of the samples taken. They wanted to know how often the tests on the samples showed abnormal cells. This is called sensitivity.

They found using AFI to identify the area of tissue and pCLE to study the cells the test results were able to show all the samples with very abnormal cells and cancer cells. So for very abnormal cells and cancer cells AFI pCLE was 100% sensitive. 

When they looked at the samples taken using AFI and NBI they found that it showed very abnormal cells and cancer cells just over 84½ times out of every 100 (84.6%). 

The researchers also looked at how often the test results showed there were abnormal cells when there wasn’t any. This is called a false positive. 

They found the percentage of false positives was:

  • just over 57½ times out of every 100 (57.6%) for AFI and pCLE samples
  • just over 52 times out of every 100 (52.1%) for AFI and EMTI samples

The team chose 3 biomarkers that are known to have a high association with abnormal cells in Barrett’s oesophagus. Using these 3 biomarkers with AFI and pCLE meant that the false positives dropped to 26 times out of every 100 (26%). This increased the sensitivity of AFI and pCLE to just over 87 times out of every 100 (87.8%). 

Conclusion
The trial team concluded that using AFI and pCLE sampling with 3 biomarkers improves the overall accuracy of diagnosing cell changes in Barrett’s oesophagus. And there needs to be future studies on a larger number of people to confirm these results. 

This study helped doctors to design another study on a larger group of patients to confirm the results. This study is called ACE-B. It is closed to recruitment and near to completion. We will write a separate summary of the results when they are available. 

Where this information comes from    
We have based this summary on information from the research team. The information they sent us has been reviewed by independent specialists (peer reviewed Open a glossary item) and published in a medical journal. The figures we quote above were provided by the trial team who did the research. We have not analysed the data ourselves.

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Dr Rebecca Fitzgerald

Supported by

BUPA Foundation
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
The Lister Institute of Preventive Medicine

Freephone 0808 800 4040

Last review date

CRUK internal database number:

5549

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Charlie took part in a trial to try new treatments

A picture of Charlie

“I think it’s really important that people keep signing up to these type of trials to push research forward.”

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