Barrett Esophagus esophageal atresia and esophageal cancer.
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: * Diagnosed with esophageal atresia OR Barrett*s Esophagus OR newly diagnosed esophageal cancer OR patients with locally advanced esophageal cancer who are in active surveillance after nCRT. * Undergo endoscopic surveillance with biopsies at the Erasmus University Medical Center. * Age above 18 years.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: * Patients with difficulties swallowing medication or with eating solid foods * Patients with a nasogastric tube. * Patients with esophageal strictures disabling passage of the capsule. * Patients with esophageal stents. * Patients who have undergone esophagectomy. * Patients with extra-esophageal malignancies including head, neck and gastric cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the accuracy (defined as sensitivity and specificity) of diagnosis with the EsophaCap sponge and an assay of selected methylated markers | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the accuracy, safety and tolerability of the combined sponge-methylation biomarker strategy; including the rate of successful retrievals of the EsophaCap (defined as retrieval of the complete EsophaCap sponge, from the stomach back into the mouth), the extracted DNA yield, a mucosal injury score, a tolerability assessment, and the preference of patients in relation to upper endoscopy. | — |
Countries
Netherlands
Outcome results
None listed