Full Title of Study: Feasibility study to assess utility of Trimodal Endoscopic Imaging to direct molecular tests on tissue samples and thereby improve prediction of individual risk of cancer and diagnosis of dysplasia in patients with Barrett’s Oesophagus
Study Objectives: Barrett’s oesophagus progresses to cancer through an intermediate stage called dysplasia. Since dysplasia can be invisible to standard endoscopy, novel imaging modalities have been proposed. The latest endoscopes (Endoscopic Trimodal Imaging or ETMI) combine standard white light endoscopy with two additional modalities called autofluorescence and narrow band imaging. ETMI has been shown to increase the detection rate of dysplasia in Barrett’s, but has high false positive rates. On the other hand, research has focused on identifying biomarkers to predict which patients with Barrett’s have the highest risk for developing dysplasia and cancer. The downside of these tissue based biomarkers is that they are assessed on random biopsies and, due to molecular heterogeneity of Barrett’s oesophagus, marker positivity can be missed in random biopsies. The TIME study is the first study that combines novel endoscopic imaging modalities (ETMI) and molecular biomarkers, with the objective to assess whether ETMI improves the detection rate for risk-stratification biomarkers.
Study design: Multicentre, non-randomized prospective study.
Participating Centres: MRC Cancer Unit and Addenbrooke's Hospital Cambridge (UK), Queens Medical Centre Nottingham University Hospital (UK), Academic Medical Centre Amsterdam (The Netherlands).
Primary endpoint: Rates of detection of molecular abnormalities with ETMI compared to standard endoscopy.
Secondary endpoint: Combination of clinical factors, ETMI and molecular biomarkers to create a multivariate model to risk-stratify patients with Barrett’s.
Patients - Inclusion criteria: Patient aged over 18 with previous diagnosis of Barrett’s at least 2 cm in length.
Patients - Exclusion criteria:
- Any other medical problem that compromises fitness for endoscopy
- Previous oesophageal surgery
- Dysphagia or swallowing difficulties
Status of the study: Recruiting.
Portfolio: The study has been adopted into the UKCRN portfolio (study ID 7561).
- R Fitzgerald, (Chief Investigator, Cambridge)
- K Ragunath (Principal Investigator, Nottingham)
- J Bergman (Principal Investigator, Amsterdam)
- M di Pietro (Clinical Researcher, Cambridge)
- K Shariff (Clinical Researcher, Cambridge)
- D Boerwinkel (Clinical Researcher, Amsterdam)
- E Telakis (Clinical Researcher, Nottingham)
- M O’Donovan (Consultant Pathologist, Cambridge)
- P Keye (Consultant Pathologist, Nottingham)
- M Visser (Consultant Pathologist, Amsterdam)
- P Lao-Sirieix (Group Research Manager, Cambridge)
- X Liu (Statistician, Cambridge)
- E Walker (Research Assistant, Cambridge)
- L Mills (Research Nurse, Cambridge)
- S Slininger (Research Nurse, Nottingham)
Medical Research Council
CLRN via UKCRN portfolio
Contacts: Leanne Mills