Safety and Feasibility of a Combined Sponge-Methylation Biomarker Strategy for the Detection of Premalignant and Malignant (early) Esophageal cancer.
- Conditions
- 10017990Barrett Esophagusesophageal atresia and esophageal cancer.
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the accuracy (defined as sensitivity and specificity) of diagnosis<br /><br>with the EsophaCap sponge and an assay of selected methylated markers </p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the accuracy, safety and tolerability of the combined<br /><br>sponge-methylation biomarker strategy; including the rate of successful<br /><br>retrievals of the EsophaCap (defined as retrieval of the complete EsophaCap<br /><br>sponge, from the stomach back into the mouth), the extracted DNA yield, a<br /><br>mucosal injury score, a tolerability assessment, and the preference of patients<br /><br>in relation to upper endoscopy.</p><br>