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A Study of Barrett's Esophagus Patients: Optimization of a Risk Model to Better Predict the Development of Cancer Recurrence and the Effect of Risk Profile Disclosure on Patient Quality of Life and Fear of Cancer

ConditionsBarrett EsophagusBarrett Esophagus AdenocarcinomaAdenocarcinoma - GEJGastroenterologyGastroenterological Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

The goal of the study is:

* The collection of various tissue samples (blood, biopsies and "esophageal brushes") and their analysis. * To test a risk model based on genetic analyses (DNA-FISH and so-called single cell sequencing) on esophageal tissue samples. * 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 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 twice 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.

Patients will have to complete questionnaires at several time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).

This study is a randomized trial, meaning the study participants will be divided into two groups by the computer. One group will be informed of their risk profile, established based on the genetic analyses. The other group will not be informed of their risk profile. All patients will be followed-up in a more intensive surveillance schedule compared to the standard of care, for study purposes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with known BE undergoing endoscopy for possible treatment by EMR or ESD due to suspicion of T1 oesophageal Barrett cancer

Capable of receiving informed consent and of giving permission

Age 18 and upward

Disqualifiers

Patients with current known malignancy of the gastrointestinal tract other than the esophageal lesion

Patients refusing randomization and corresponding follow-up intervals based on biomarker profile

Patients with severe co-morbidity that prohibits endoscopic therapy under sedation or conscious sedation (such as severe cardiac or pulmonary disease)

Esophageal varices

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risk profile disclosure

    Other intervention

    Participants in the intervention arm will be informed by the investigator on their genetic risk profile.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Disease recurrence

Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia

Time frame
From endoscopic resection up to three years after endoscopic eradication therapy
2

Cancer Worry Scale

Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)

Time frame
After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
3

Economic costs

Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)

Time frame
From end of endoscopic eradication therapy until three years after endocsopic eradication therapy

Secondary outcomes

1

Clonal diversity score

Clonal diversity score measurements based on DNA-FISH brush cytology samples before and after endoscopic resection

Time frame
Between the baseline endoscopy (visit 1) and first endoscopy after endoscopic resection (visit 2)
2

Disease stage

Disease stage (histopathological disease stage of resection specimen, TNM-classification) based on EMR/ESD, EUS, PET-CT, pathology and cytology

Time frame
From patient inclusion until three years after endoscopic eradication therapy
3

Missing data ePRO

Missing data events for ePRO and paper questionnaires

Time frame
From start of inclusion until three years after endoscopic eradication
4

Caregiver's satisfaction

Caregiver's responses to questionnaire on application of biomarker-based health information

Time frame
From start inclusion until three years after endoscopic eradication

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

Karolinska Institutet

Collaborator

Karolinska University Hospital

Collaborator

Amsterdam UMC

Collaborator

Radbound University Medical Center

Collaborator

University of Leipzig

Collaborator

IRCCS Ospedale San Raffaele

Collaborator

University of Dublin, Trinity College

Collaborator

St. James's Hospital, Ireland

Collaborator

Heinrich-Heine University, Duesseldorf

Collaborator

Rigshospitalet, Denmark

Collaborator

Universitätsklinikum Leipzig

Collaborator

GZA Ziekenhuizen Campus Sint-Augustinus

Collaborator

AZ Delta

Collaborator

University Hospital, Lille

Collaborator

University Hospital, Ghent

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: