Trial Title:
A Study of Barrett's Esophagus Patients to Investigate Quality of Life and Fear of Cancer, and Optimize a Risk Model Based on Biomarkers and New Technologies to Better Predict the Development of Cancer
NCT ID:
NCT06523374
Condition:
Barrett's Esophagus
Esophageal Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Barrett Esophagus
Esophageal Neoplasms
Conditions: Keywords:
Barrett
Barrett's Esophagus
Endeavor
Esophageal cancer
Esophageal adenocarcinoma
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Endoscopic brush cytology
Description:
A total of four brush samples will be taken during the endoscopy. Other minimally
invasive interventions during this study are standard of care.
Arm group label:
Endoscopic brush cytology
Summary:
This study serves, in part, to prepare for a future large cohort study. The goal of the
study is:
1. The collection of various tissue samples (blood, biopsies and "esophageal brushes")
and their analysis.
2. To set up standardized methods for different genetic analyses (DNA-FISH and
so-called single cell sequencing) on the esophageal tissue samples.
3. Evaluating the quality of life of Barrett's Esophagus patients and the degree of
fear of getting cancer.
Patients with a Barrett's Esophagus can participate in the study if they are minimally 18
years old, are capable of giving informed consent (fully understanding what the study
entails before giving consent to participate), have Barrett Esophagus and are referred to
one of the participating centers due to suspicion of high-grade dysplasia or early
esophageal cancer, for which the participant will be evaluated by endoscopic imaging and
biopsy.
Study procedures:
- An intake consultation will be planned, wherein the eligibility criteria will be
assessed, and participant characteristics will be collected.
- A routine gastroscopy will be planned during which several minimally-invasive
interventions will be performed: drawing a blood sample, brush cytology during the
endoscopy (a brush is used to obtain cells from the surface of the esophagus) and
obtaining biopsy samples (small pieces of tissue). Each participant will need to
undergo all the interventions.
Detailed description:
More specifically, you will have a standard endoscopy during which tissue samples will be
taken from the esophagus to check for the severity of the disease. This is part of
standard care. If you participate in the study, additional samples will be taken from the
esophagus and also from the stomach (a total maximum of 10 samples of 1-2 mm). As a
result, the endoscopic examination will take about 10-15 minutes longer than standard.
Furthermore, in addition to the tissue samples, cells of the esophageal mucosa will be
sampled (through 4 "esophageal brushes") and blood (4 tubes) will also be collected.
For this study, you will be contacted a total of two times. Once for a screening visit
and once for the sample collection described above. The screening and sample collection
will take place during the already scheduled treatments and consultations. Afterwards,
patient outcomes will be documented for the study until a maximum of 5 years after
inclusion. This documentation will take place during the routine follow up so does not
require any additional visits for the patients.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due
to suspicion of early esophageal Barrett cancer
- Capable of receiving informed consent and of giving permission
- Age 18 and upward
Exclusion Criteria:
- Patients with current known malignancy of the gastrointestinal tract other than the
esophageal lesion
- Patients with severe co-morbidity that prohibits endoscopic therapy under sedation
or conscious sedation (such as severe cardiac or pulmonary disease)
- Esophageal varices
- Uncontrollable coagulation disorders
- Undergoing chemotherapy or immunotherapy or received chemotherapy < 6 weeks prior to
endoscopy
- Undergoing radiotherapy within the esophageal region or received chemotherapy < 6
months prior to endoscopy
- WHO score > 3
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Hospital Antwerp
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Contact:
Last name:
Toon Mertens
Phone:
+3234368281
Email:
toon.mertens@uza.be
Contact backup:
Last name:
Luka Van der Veken
Phone:
+3234368249
Email:
luka.vanderveken@uza.be
Investigator:
Last name:
Prof. Dr. Sheila Krishnadath
Email:
Principal Investigator
Facility:
Name:
Sint-Augustinus Hospital (ZAS)
Address:
City:
Wilrijk
Zip:
2610
Country:
Belgium
Contact:
Last name:
Toon Mertens
Phone:
+32 34 36 8281
Email:
toon.mertens@uza.be
Investigator:
Last name:
Dr. Thomas Botelberge
Email:
Principal Investigator
Facility:
Name:
UZ Gent
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Contact:
Last name:
Dr. David Tate
Phone:
0032 9 332 23 00
Email:
david.tate@uzgent.be
Investigator:
Last name:
Dr. David Tate
Email:
Principal Investigator
Facility:
Name:
AZ Delta
Address:
City:
Roeselare
Zip:
8800
Country:
Belgium
Contact:
Last name:
Dr. Dominiek De Wulf
Phone:
+32 51 23 72 15
Investigator:
Last name:
Dr. Dominiek De Wulf
Email:
Principal Investigator
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
2100
Country:
Denmark
Contact:
Last name:
Prof. Dr. Michael Patrick Achiam
Phone:
+45 35 45 04 41
Email:
michael.patrick.achiam.01@regionh.dk
Investigator:
Last name:
Prof. Dr. Michael Patrick Achiam
Email:
Principal Investigator
Facility:
Name:
CHU LILLE - Centre Hospitalier Universitaire de Lille
Address:
City:
Lille
Zip:
59000
Country:
France
Contact:
Last name:
Florence Nosal
Phone:
+33320445751
Email:
florence.nosal@chru-lille.fr
Investigator:
Last name:
Prof. Dr. Guillaume Piessen
Email:
Principal Investigator
Facility:
Name:
University Hospital Leipzig
Address:
City:
Leipzig
Zip:
04103
Country:
Germany
Contact:
Last name:
Dr. René Thieme
Phone:
+49 341 97 20809
Email:
Rene.Thieme@medizin.uni-leipzig.de
Investigator:
Last name:
Prof. Dr. Ines Gockel
Email:
Principal Investigator
Facility:
Name:
St James's Hospital
Address:
City:
Dublin
Zip:
D08 NHY1
Country:
Ireland
Contact:
Last name:
Prof. Jacintha O'Sullivan
Phone:
+353 1 8962149
Email:
OSULLIJ4@tcd.ie
Investigator:
Last name:
Prof. Jacintha O Sullivan
Email:
Principal Investigator
Facility:
Name:
IRCCS Ospedale San Raffaele
Address:
City:
Milano
Zip:
20132
Country:
Italy
Contact:
Last name:
Dr. Federica Ungaro
Phone:
+39 0226437864
Email:
Ungaro.Federica@hsr.it
Investigator:
Last name:
Dr. Silvio Danese
Email:
Principal Investigator
Facility:
Name:
Karolinska University Hospital
Address:
City:
Solna
Zip:
SE-171 76
Country:
Sweden
Contact:
Last name:
Dr. Fredrik Klevebro
Email:
fredrik.klevebro@regionstockholm.se
Investigator:
Last name:
Dr. Fredrik Klevebro
Email:
Principal Investigator
Start date:
November 2024
Completion date:
November 2026
Lead sponsor:
Agency:
University Hospital, Antwerp
Agency class:
Other
Collaborator:
Agency:
Karolinska Institutet
Agency class:
Other
Collaborator:
Agency:
Universal Diagnostics
Agency class:
Industry
Collaborator:
Agency:
Amsterdam UMC
Agency class:
Other
Collaborator:
Agency:
Radboud University Medical Center
Agency class:
Other
Collaborator:
Agency:
AZ Delta
Agency class:
Other
Collaborator:
Agency:
Centre Hospitalier Universitaire de Liege
Agency class:
Other
Collaborator:
Agency:
University of Leipzig
Agency class:
Other
Collaborator:
Agency:
IRCCS Ospedale San Raffaele
Agency class:
Other
Collaborator:
Agency:
Karolinska University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Dublin, Trinity College
Agency class:
Other
Collaborator:
Agency:
Heinrich-Heine University, Duesseldorf
Agency class:
Other
Collaborator:
Agency:
GZA Ziekenhuizen Campus Sint-Augustinus
Agency class:
Other
Collaborator:
Agency:
University Hospital, Ghent
Agency class:
Other
Collaborator:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Universitätsklinikum Leipzig
Agency class:
Other
Collaborator:
Agency:
St. James's Hospital, Ireland
Agency class:
Other
Source:
University Hospital, Antwerp
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06523374
