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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Disease recurrence — From endoscopic resection up to three years after endoscopic eradication therapy
  Extraluminal recurrence (regional, distal) of cancer, endoluminal recurrence (metachronous, local) of cancer, endoluminal recurrence of dysplasia
• Cancer Worry Scale — After cessation of endoscopic eradication therapy (EET), assessed up to 5 years after inclusion
  Cancer Worry Scale (total score, 8-item version) after cessation of endoscopic eradication therapy (EET)
• Economic costs — From end of endoscopic eradication therapy until three years after endocsopic eradication therapy
  Economic costs in euro for surveillance programme (including endoscopic procedures, biomarker analysis and materials)

Trial sites (10)

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