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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03222635




Registration number
NCT03222635
Ethics application status
Date submitted
17/07/2017
Date registered
19/07/2017

Titles & IDs
Public title
Prospective Endoscopic Follow-up of Patients With Submucosal and High Risk Mucosal Esophageal Adenocarcinoma
Scientific title
Endoscopic Management of Patients With High Risk T1a and T1b N0M0 Esophageal Adenocarcinoma: a Prospective Multicenter Registry.
Secondary ID [1] 0 0
NL6116501817
Universal Trial Number (UTN)
Trial acronym
PREFER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Submucosal Esophageal Adenocarcinoma 0 0
Barrett Esophagus 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
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Endoscopic follow-up

Experimental: Endoscopic follow-up - Patients treated with endoscopic resection (ER) for a submucosal or high-risk mucosal esophageal adenocarcinoma without lymphnode- or distant metastases (N0M0) will undergo endoscopic follow-up.


Treatment: Surgery: Endoscopic follow-up
Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
5-year disease-specific mortality/survival (descriptive statistics in SPSS, percentages, survival analysis)
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Overall survival (descriptive statistics in SPSS, percentages, survival analysis)
Timepoint [2] 0 0
5 years
Secondary outcome [1] 0 0
Lymph node metastasis, confirmed by cytology and/or histology (descriptive statistics in SPSS, number of patients (%))
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Local recurrence eligible for endoscopic therapy (descriptive statistics in SPSS, number of patients (%))
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Local recurrence requiring surgical therapy (descriptive statistics in SPSS, number of patients (%))
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Distant metastasis, histologically proven (descriptive statistics in SPSS, number of patients (%))
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Quality of life during follow-up endoscopies (questionnaires)
Timepoint [5] 0 0
5 years

Eligibility
Key inclusion criteria
* Patients with submucosal or high-risk mucosal EAC diagnosed in an ER specimen, by an expert gastrointestinal (GI) pathologists.
* Signed informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior history of high-risk mucosal or =T1sm.
* Synchronous esophageal squamous cell carcinoma.
* Suspicion on lymph node metastasis or distant metastasis on EUS, ultrasound of the neck or CT-thorax-abdomen performed six weeks after ER during baseline measurement.
* Tumor-positive deep resection margin (R1) in ER specimen.
* Patients unable to give signed informed consent.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/07/2028
Actual
Sample size
Target
225
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
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Gent
Country [3] 0 0
Belgium
State/province [3] 0 0
Leuven
Country [4] 0 0
Belgium
State/province [4] 0 0
Roeselare
Country [5] 0 0
Germany
State/province [5] 0 0
Augsburg
Country [6] 0 0
Germany
State/province [6] 0 0
Duesseldorf
Country [7] 0 0
Germany
State/province [7] 0 0
Münich
Country [8] 0 0
Germany
State/province [8] 0 0
Regensburg
Country [9] 0 0
Netherlands
State/province [9] 0 0
Amsterdam
Country [10] 0 0
Netherlands
State/province [10] 0 0
Eindhoven
Country [11] 0 0
Netherlands
State/province [11] 0 0
Groningen
Country [12] 0 0
Netherlands
State/province [12] 0 0
Nieuwegein
Country [13] 0 0
Netherlands
State/province [13] 0 0
Nijmegen
Country [14] 0 0
Netherlands
State/province [14] 0 0
Rotterdam
Country [15] 0 0
Netherlands
State/province [15] 0 0
The Hague
Country [16] 0 0
Netherlands
State/province [16] 0 0
Zwolle
Country [17] 0 0
Switzerland
State/province [17] 0 0
Zürich
Country [18] 0 0
United Kingdom
State/province [18] 0 0
London
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
Amsterdam UMC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
J. J. Bergman, MD, PhD
Address 0 0
Amsterdam UMC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Vincent Bos, MD
Address 0 0
Country 0 0
Phone 0 0
+31204445500
Fax 0 0
Email 0 0
v.bos@amsterdamumc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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/NCT03222635