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)


SPECTRE-study


- candidate number24117
- NTR NumberNTR5735
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-mrt-2016
- Secondary IDsAMC METC 2015_323 
- Public TitleSPECTRE-study
- Scientific TitleImproved screening of esophageal cancer by optical detection of field cancerization
- ACRONYMSPECTRE
- hypothesisScreening of esophageal cancer can be improved by the optical detection of field cancerization
- Healt Condition(s) or Problem(s) studiedBarrett'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 receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 4-apr-2016
- planned closingdate1-nov-2018
- Target number of participants60
- InterventionsOptical measurements will be performed on several locations in the esophagus. Biopsies will also be obtained. Brush cytology will be obtained.
- Primary outcomeThe 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 outcomeThe secondary objective is to investigate the biological background of field cancerization detected by ESS
- Timepointsnot applicable
- Trial web sitenone
- statusplanned
- 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), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsNone yet
- Brief summaryBarrett'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)
- RECORD15-mrt-2016 - 22-mei-2016


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