|- candidate number||24117|
|- NTR Number||NTR5735|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||15-mrt-2016|
|- Secondary IDs||AMC METC 2015_323 |
|- Public Title||SPECTRE-study|
|- Scientific Title||Improved screening of esophageal cancer by optical detection of field cancerization|
|- hypothesis||Screening of esophageal cancer can be improved by the optical detection of field cancerization|
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Esophageal cancer|
|- Inclusion criteria||- Age > 18 years.|
- Known BE, defined as columnar lined epithelium of the esophagus containing intestinal metaplasia upon biopsy.
- Signed informed consent.
|- Exclusion criteria||- Contraindications for ER and/or obtain biopsies (e.g. due to anticoagulation, coagulation disorders, esophageal varices).|
- Presence of an advanced lesion (e.g. type 0-I or type 0-III) not amendable for endoscopic resection (T1b).
- Presence of erosive esophagitis (Los Angeles classification ¡ƯA).
- Unable to provide signed informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||4-apr-2016|
|- planned closingdate||1-nov-2018|
|- Target number of participants||60|
|- Interventions||Optical measurements will be performed on several locations in the esophagus. Biopsies will also be obtained. Brush cytology will be obtained.|
|- Primary outcome||The primary objective of our study is to evaluate the feasibility of using MDSFR combined with OCT for the detection of field cancerization in Barrett esophagus patients.|
|- Secondary outcome||The secondary objective is to investigate the biological background of field cancerization detected by ESS|
|- Timepoints||not applicable|
|- Trial web site||none|
|- CONTACT FOR PUBLIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. J.J.G.H.M. Bergman|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Publications||None yet|
|- Brief summary||Barrett's esophagus (BE) is a precursor lesion for esophageal adenocarcinoma. Therefore, the current Barrett's surveillance protocol consists of white light endoscopy and random biopsies. Field cancerization is based on the concept that focal cancers arise in tissue areas with random genetic changes. Light scattering spectroscopy might be able to detect this field cancerization and therefore be an innovative approach to improve detection of prevalent neoplasia in BE patients.
In this study, we will evaluate the feasibility of optical detection of field cancerization in BE patients.|
|- Main changes (audit trail)|
|- RECORD||15-mrt-2016 - 22-mei-2016|