Clinical trial NCT06523374: 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
Official title: Endoscopic Brush Cytology and Single Cell Clonal Dynamics of Early Esophageal Adenocarcinoma for Defining Cost Effective Surveillance Strategies and Prediction of Cancer Recurrence: Prospective Pilot Cohort Study in Preparation of a Randomized Controlled Trial to Determine the Feasibility of a Risk Stratification Model for Barrett Esophagus Patients Based on Brush Cytology, and to Test Novel High Throughput Methods for Assessing Biomarkers for Future Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Barrett's Esophagus
Esophageal Adenocarcinoma
Keywords: Barrett
Barrett's Esophagus
Endeavor
Esophageal cancer
Esophageal adenocarcinoma
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Universal Diagnostics
name: Amsterdam UMC
name: Radboud University Medical Center
name: AZ Delta
name: Centre Hospitalier Universitaire de Liege
name: University of Leipzig
name: IRCCS Ospedale San Raffaele
name: Karolinska University Hospital
name: University of Dublin, Trinity College
name: Heinrich-Heine University, Duesseldorf
name: GZA Ziekenhuizen Campus Sint-Augustinus
name: University Hospital, Ghent
name: Rigshospitalet, Denmark
name: Universitätsklinikum Leipzig
name: St. James's Hospital, Ireland
First posted: 2024-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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

Primary outcomes:
measure: Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies
timeFrame: 6-12 months
measure: Success rate of DNA-FISH analyses on the brush cytology samples
timeFrame: 6-12 months
Secondary outcomes:
measure: Accuracy of a DNA-FISH based risk model
timeFrame: 6-24 months
measure: Correlation of a DNA-FISH based risk model
timeFrame: 6-24 months
measure: Standard operating procedures for specimen collection
timeFrame: 6-24 months
measure: Standard operating procedures for logistical procedures
timeFrame: 6-24 months
measure: Successful participation and answering of questionnaires
timeFrame: 6-24 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerpen
city: Wilrijk
country: Belgium
facility: Sint-Augustinus Hospital (ZAS)
state: Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: Roeselare
country: Belgium
facility: AZ Delta
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Lille
country: France
facility: CHU LILLE - Centre Hospitalier Universitaire de Lille
city: Leipzig
country: Germany
facility: University Hospital Leipzig
city: Dublin
country: Ireland
facility: St James's Hospital
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Solna
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Universitair Ziekenhuis Antwerpen (UZA)
name: Sheila Krishnadath
role: PRINCIPAL_INVESTIGATOR
References: