NCT04818476|Unknown
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Sponsor study identifier
observational
1,000
7 countries
16
Study Start
February 10, 2020
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess lymph node metastasis rate, distant metastasis rate, disease-specific mortality, and overall mortality in patients with Barrett's related T1b and high risk T1a esophageal adenocarcinoma (EAC) who underwent a diagnostic endoscopic resection.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 10, 2020
Actual (reported)March 24, 2021
Actual (reported)March 26, 2021
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
lymph node metastasis rate
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies
10 years
distant metastasis rate
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
10 years
disease-specific mortality
Disease specific mortality is decribed as mortality directly linked to the esophageal adenocarcinoma (i.e., metastasized EAC, metastasized disease with a simultaneously primary cancer present and it cannot be ruled out (based on histology) that the metastases are related to the other primary cancer, death due to complications of the endoscopic procedure, death due to complications after surgery or CRT, no clear cause of death in patients who have metastases or untreated local recurrence). If patients are diagnosed with distant metastases, and subsequently die of a non-tumor related cause, patients will still be documented as tumor-related death. Will be measured in number of patients and percentages. Survival analysis using Kaplan Meier will be performed.
Patients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0)
Patients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0)
Patients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0)
diagnostic endoscopic resection
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients who underwent a diagnostic ER for Barrett's related HR T1a or T1b EAC in one of the participating centers, from 1/1/2008 up to the moment of data collection.
Westmead hospital
Sydney, Australia
UZ Gasthuisberg
Leuven, Belgium
CHU Nantes
Nantes, France
R.E. Pouw, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First Submitted
March 24, 2021
First Posted
March 26, 2021
Study Start
February 10, 2020
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)Predict Recurrence of Barrett's Esophagus After Complete Eradication of Intestinal Metaplasia
Detection of Barrett s Esophagus in Patients Without GERD Symptoms
10 years
overall mortality
Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
10 years
Contact the study team to confirm eligibility.
Universitätsklinikum Augsburg
Augsburg, Germany
EVK Duesseldorf
Düsseldorf, Germany
MRI TUM
Münich, Germany
Barmherzige Brüder Regensburg
Regensburg, Germany
Amsterdam UMC, location VUmc
Amsterdam, Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Erasmus MC - University Medical Center
Rotterdam, Netherlands
Haga Medical Center
The Hague, Netherlands
Isala Clinics
Zwolle, Netherlands
Hirslanden private hospital group
Zurich, Switzerland
University College London Hospital
London, United Kingdom
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 26, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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