Analysis of tissue samples from gastrointestinal disease screening patients using optical methods for development of a rapid-bedside sample triaging system to reduce pathology workloads

Not Applicable

Completed

• Conditions: Barrett's oesophagus/oesophageal adenocarcinoma, colorectal adenocarcinoma/polyps; Digestive System; 1. Barrett's oesophagus/oesophageal adenocarcinoma 2. Colorectal adenocarcinoma/polyps

• Registration Number: ISRCTN16956408
• Lead Sponsor: BeamLine Diagnostics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-20
• Study Completion: 2018-09-30
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Confirmed or suspected Barrett’s oesophagus, undergoing endoscopy
2. Being admitted for general colonoscopy, referred from the bowel cancer screening programme or the flexi-sigmoidoscopy screening programme
3. Patients without Barrett’s oesophagus attending for a clinically indicated endoscopy may be recruited as controls
4. Signing of an informed consent form

Exclusion Criteria

1. Patients in whom endoscopy/colonoscopy and biopsy is contraindicated
2. Patients who are unable to give informed consent
3. Pregnant women
4. Under the age of 18 years
5. Non-English speakers

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The sensitivity and specificity of the Solas algorithm is measured by comparing the number of true negatives versus false positives as determined by histopathology result at study completion (average two weeks)<br><br> The Solas algorithm will produce a measure of the probability (p-value) that the the sample is healthy. By varying the p-value threshold - the value used to determine the p-value at which a sample should be classed as either healthy/benign or diseased - a Receiver Operating Characteristic (ROC) curve will be produced. From this the most effective combination of sensitivity and specificity can be determined.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. The sensitivity of Solas compared to the biopsy result is measured using the percentage of False positive and false negative rate as determined by histopathology at the time of study completion (on average two weeks)<br> 2. The positive predictive value (PPV) of Solas compared to the biopsy result is measured using the percentage of true positives versus false positives identified as determined by histopathology at study completion (on average two weeks)<br> 3. The negative predictive value (NPV) of Solas compared to the biopsy result is measured using the percentage of trust negatives versus the percentage of false negatives identified as determined by histopathology at study completion (on average two weeks)<br>