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

Condition(s) studied

Investigational drug(s) / intervention(s)

Endoscopic brush cytology: A total of four brush samples will be taken during the endoscopy. Other minimally invasive interventions during this study are standard of care.

Study 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 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 three time points to assess their quality of life (EQ-5D-DL questionnaire) and fear of cancer recurrence (Cancer Worry Scale).

Eligibility

Primary outcome measure(s)

• Success rate of brush, biopsy and blood samples obtained from different sites for analysis by HTP technologies — 6-12 months
  We will determine the success rate of obtaining material from different sites for analysis by high throughput technologies (Next Generation Sequencing) of the brush, biopsy or blood samples. A rate of analysable cells of at least 80% of the specimens will be regarded as successful.
• Success rate of DNA-FISH analyses on the brush cytology samples — 6-12 months
  Our second primary outcome measure for this pilot study is successful DNA-FISH analysis (successful = at least 50 cells that can be analyzed in at least 80% of participants) on the brush cytology samples for defining the final risk model that will be applied in the randomized controlled trial following the pilot study.

Trial sites (9)

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