search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Proteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.


- candidate number10968
- NTR NumberNTR3249
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jan-2012
- Secondary IDs11/096 METC AMC
- Public TitleProteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.
- Scientific TitleProteomics in early neoplasia in Barrett's esophagus: Biomarkers for early detection.
- ACRONYM
- hypothesisBy 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) studiedBarrett's esophagus, Barrett's cancer, Barrett's neoplasia, Barrett's dysplasia
- Inclusion criteriaInclusion 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 criteriaExclusion 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-apr-2011
- planned closingdate1-mrt-2013
- Target number of participants20
- InterventionsDysplastic group:
Non additional.

Non-dysplastic group:
Endoscopic resection (ER-cap technique) of non-dysplastic Barrett's esophagus.
- Primary outcomeIdentification of peptides and proteins which could indicate presence of early neoplasia in a Barrett's esophagus.
- Secondary outcome1. 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.
- TimepointsMay-2012: Interim analysis of 5 dysplastic vs 5 non-dysplastic samples;
March-2013: Complete analysis of all obtained ER samples.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. dr. J.J.G.H.M. Bergman
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.G.H.M. Bergman
- Sponsor/Initiator Academic Medical Center (AMC), Department of Hepato- and Gastroenterology, Erasmus Medical Center, Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Hepato- and Gastroenterology, Erasmus Medical Center, Department of Neurology
- PublicationsN/A
- Brief summaryThe 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)
- RECORD18-jan-2012 - 30-jan-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl