|- candidate number||10968|
|- NTR Number||NTR3249|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jan-2012|
|- Secondary IDs||11/096 METC AMC|
|- Public Title||Proteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.|
|- Scientific Title||Proteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.|
|- hypothesis||By comparing protein profiles of dysplastic vs non-dysplastic Barrett epithelium, a novel biomarker for prediction of early neoplasia may be identified. |
|- Healt Condition(s) or Problem(s) studied||Barrett's esophagus, Barrett's cancer, Barrett's neoplasia, Barrett's dysplasia|
|- Inclusion criteria||Inclusion criteria ‘dysplastic’ group:|
1. Scheduled ER for Barrett’s esophagus containing HGD or early cancer;
2. Review of biopsies and histopathology specimens by an expert local pathologist;
3. Written informed consent.
Inclusion criteria ‘non-dysplastic’ group:
1. Scheduled surveillance endoscopy for Barrett’s esophagus without dysplasia;
2. No dysplasia in biopsies, or biopsies ‘indefinite for dysplasia’ during at least the last two years;
3. No visible abnormalities in Barrett’s esophagus in the two most recent surveillance endoscopies;
4. Review of biopsies and histopathology specimens by an expert local pathologist;
5. Written informed consent.
|- Exclusion criteria||Exclusion criteria ‘dysplastic’ group:|
1. In case histopathological assessment of the frozen half of the ER specimen is necessary for clinical decision making, the specimen will be retrieved from the Barrett’s research tissue bank and further processed for clinical care.
Exclusion criteria ‘non-dysplastic’ group:
1. Patients that are not suitable candidates for ER because of co-morbidity.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-apr-2011|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||20|
|- Interventions||Dysplastic group:|
Endoscopic resection (ER-cap technique) of non-dysplastic Barrett's esophagus.
|- Primary outcome||Identification of peptides and proteins which could indicate presence of early neoplasia in a Barrett's esophagus.|
|- Secondary outcome||1. Number of identified proteins per cell-surface area;|
2. Differences and similarities between protein profiles of dysplastic vs non-dysplastic ER-samples in:
A. Epithelial cells;
B. Stromal cells.
|- Timepoints||May-2012: Interim analysis of 5 dysplastic vs 5 non-dysplastic samples;|
March-2013: Complete analysis of all obtained ER samples.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- 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), Department of Hepato- and Gastroenterology, Erasmus Medical Center, Department of Neurology|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), Department of Hepato- and Gastroenterology, Erasmus Medical Center, Department of Neurology|
|- Brief summary||The purpose of this project is to compare the protein profile of Barrett's mucosa with and without early neoplasia in ER specimens in epithelial and stromal cells aiming to identify a biomarker indicating presence of early neoplasia in BE. |
|- Main changes (audit trail)|
|- RECORD||18-jan-2012 - 30-jan-2012|