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

Optical Research for Biopsy Triaging (ORBiT): infrared analysis of gastrointestinal tract tissue specimens

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN16956408

Enrollment

400

Registered

2017-06-20

Start date

2017-05-05

Completion date

Unknown

Last updated

2020-03-30

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

Conditions

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

Interventions

Participants are recruited from patients attending clinic for an endoscopy or colonscopy. Biopsy/polyp samples taken for analysis by histopathology, are first be scanned on an infrared spectrometer. T

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) 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.	—

Measure

Time frame

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) 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.

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Secondary

Measure	Time frame
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) 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) 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)	—

Measure

Time frame

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) 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) 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)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026