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Barrett’s oesophagus surveillance with optical biopsy using spectroscopy and enhanced endoscopic imaging to target high-risk lesions

Barrett’s oesophagus surveillance with optical biopsy using spectroscopy and enhanced endoscopic imaging to target high-risk lesions: a prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN58235785
Enrollment
2000
Registered
2016-09-30
Start date
2008-06-05
Completion date
Unknown
Last updated
2017-08-28

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

Conditions

Barrett's oesophagus, dysplasia, aneuploidy or other molecular abnormalities and oesophageal adenocarcinoma Cancer

Interventions

A series of optical measurements are taken followed by routine biopsies, some of which may be initially examined ex vivo using ESS and/or FTIRS before being sent for histological evaluation. Correlati

Sponsors

UCL Biomedical Research Unit
Lead Sponsor
University College London Hospital
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients will be recruited from those with Barrett’s oesophagus with or without other alterations (low-grade dysplasia [LGD] or high-grade dysplasia [HGD], any oesophageal or gastric cancer) undergoing endoscopy 2. Patients without Barrett’s oesophagus attending for a clinically indicated endoscopy may be recruited as controls 3. Patients must sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients in whom endoscopy and biopsy is contraindicated 2. Patients who are unable to give informed consent 3. Pregnant women 4. People under the age of 21 years 5. People who are non-English speakers

Design outcomes

Primary

MeasureTime frame
1. Predictive accuracy of in vivo ESS for future cancer risk, particularly in patients undergoing routine endoscopic surveillance who are at low risk of progressing to oesophageal cancer 2. Ability to correlate endoscopy findings with cancer risk using genetic analysis of tissue or fluid samples 3. Predictive accuracy of ex vivo ESS and/or FTIRS for future cancer risk, particularly in patients undergoing routine endoscopic surveillance who are at low risk of progressing to oesophageal cancer 4. Ability of in vivo ESS to target biopsies to areas of dysplasia, aneuploidy or other molecular abnormalities

Secondary

MeasureTime frame
Ability of enhanced endoscopic imaging techniques including iScan to improve dysplasia detection and minimize the need for biopsies during endoscopic surveillance procedures

Countries

United Kingdom

Outcome results

None listed

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