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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04818476




Registration number
NCT04818476
Ethics application status
Date submitted
24/03/2021
Date registered
26/03/2021

Titles & IDs
Public title
Outcomes of Endoscopically Resected High-risk Mucosal and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus
Scientific title
Outcomes of Endoscopically Resected High-risk Mucosal Adenocarcinoma and Low- and High-risk Submucosal Adenocarcinoma Arising in Barrett's Esophagus: an International Multicenter Retrospective Cohort Study
Secondary ID [1] 0 0
x
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrett Esophagus 0 0
Adenocarcinoma Esophagus 0 0
Submucosal Esophageal Adenocarcinoma 0 0
High-risk Mucosal Esophageal Adenocarcinoma 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - diagnostic endoscopic resection

HR-T1a - Patients who weretreated by radical endoscopic resection for a high-risk mucosal EAC (HR-T1a N0M0)

LR-T1b - Patients who were treated by radical endoscopic resection for a low-risk submucosal EAC (LR-T1b N0M0)

HR-T1b - Patients who were treated by radical endoscopic resection for a high-risk submucosal EAC (HR-T1b N0M0)


Treatment: Surgery: diagnostic endoscopic resection
diagnostic endoscopic resection
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
lymph node metastasis rate
Assessment method [1] 0 0
Confirmed by cytology and/or histology by performing FNA during EUS or biopsies
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
distant metastasis rate
Assessment method [2] 0 0
Primary tumor of distant metastasis should be histopathologically evalueted by taking biopsies.
Timepoint [2] 0 0
10 years
Primary outcome [3] 0 0
disease-specific mortality
Assessment method [3] 0 0
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.
Timepoint [3] 0 0
10 years
Primary outcome [4] 0 0
overall mortality
Assessment method [4] 0 0
Overall mortality of study population (tumor-related + non-tumor-related deaths). Measured in numbers and percentages, survival analysis (KM).
Timepoint [4] 0 0
10 years

Eligibility
Key inclusion criteria
1. Males or females, all ages
2. Endoscopic resection of a histologically proven high risk T1a, low risk T1b EAC, or high risk T1b EAC
3. Between 1/1/2008 and 1/1/2019
4. Endoscopic resection and endoscopic FU (or other treatment after ER) have taken place in the participating center
5. No written or oral refusal to use subject's data
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criterium:

Objection against participation in this study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Westmead hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Leuven
Country [2] 0 0
France
State/province [2] 0 0
Nantes
Country [3] 0 0
Germany
State/province [3] 0 0
Augsburg
Country [4] 0 0
Germany
State/province [4] 0 0
Duesseldorf
Country [5] 0 0
Germany
State/province [5] 0 0
Münich
Country [6] 0 0
Germany
State/province [6] 0 0
Regensburg
Country [7] 0 0
Netherlands
State/province [7] 0 0
Amsterdam
Country [8] 0 0
Netherlands
State/province [8] 0 0
Eindhoven
Country [9] 0 0
Netherlands
State/province [9] 0 0
Groningen
Country [10] 0 0
Netherlands
State/province [10] 0 0
Nieuwegein
Country [11] 0 0
Netherlands
State/province [11] 0 0
Rotterdam
Country [12] 0 0
Netherlands
State/province [12] 0 0
The Hague
Country [13] 0 0
Netherlands
State/province [13] 0 0
Zwolle
Country [14] 0 0
Switzerland
State/province [14] 0 0
Zürich
Country [15] 0 0
United Kingdom
State/province [15] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
R.E. Pouw, MD, PhD
Address 0 0
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Man Wai Chan, MD
Address 0 0
Country 0 0
Phone 0 0
(0)20 4442432
Email 0 0
m.w.chan@amsterdamumc.nl
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04818476