Clinical Research Directory

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

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.

"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.

Rationale: Until recently, the conventional strategy outlined by both national and international guidelines for managing non-dysplastic (ND) Barrett esophagus (BE), involved endoscopic surveillance at 3 to 5 year intervals, aiming to reduce mortality from esophageal adenocarcinoma (EAC) through early detection and treatment. However, scientific evidence that supports the benefits in EAC-specific and/or overall survival, or that shows cost-effectiveness, is lacking. This has led to a re-evaluation of surveillance practices, particularly for NDBE patients at low risk of progression to EAC. For this reason, and in light of the 'NVMDL knowledge agenda,' a recent adjustment has been made to the Dutch guideline, recommending discontinuation of endoscopic surveillance for low-risk NDBE patients, hypothesizing that discontinuing endoscopic surveillance in low-risk NDBE patients will not lead to a relevant increase in the incidence of clinically significant EAC. This study aims to evaluate long-term outcomes of this guideline change. Objective: The primary objective is to evaluate the incidence of clinically apparent EAC after discontinuation of endoscopic surveillance in low-risk NDBE patients. Study design: This is a nationwide, prospective, single-arm observational study with a minimum duration of 10 years. All patients in the Netherlands, eligible for study participation, will be approached and, upon signing informed consent, included in this care evaluation project. Baseline information will be collected from endoscopy and pathology reports and the electronic patient files. During follow-up, data will be collected from existing registries, including the national pathology database named Pathologisch-Anatomisch Landelijk Geautomatiseerd Archief (PALGA), the national statistics database named: Central Bureau van Statistiek (CBS), Integraal Kankercentrum Nederland (IKNL), and if necessary, additional information will be collected from electronic patient files in patient's hospital or the general practitioner. On an annual basis, study outcomes will be evaluated and reviewed by a DSMB according to pre-defined stopping rules. Study population: All low-risk NDBE patients in the Netherlands in whom endoscopic surveillance will no longer be indicated based on the new Dutch guideline recommendations will be included. This includes patients with (1) BE with a maximum extent \<5cm in length; (2) without (a history of) dysplasia; and (3) without a family history for EAC. A family history of EAC is defined as at least one first-degree relative with esophageal cancer. Main study parameters/endpoints: Primary study endpoint: the annual incidence of patients with clinically apparent EAC during a minimum follow-up of 10 years. Clinically apparent EAC is defined as one of the following: * EAC related death, and/or * EAC that exceeds boundaries for curative endoscopic treatment, defined as any symptomatic EAC that undergoes (1) palliative treatment; (2) esophagectomy; (3) chemotherapy; (4) radiotherapy; (5) immunotherapy; and/or (6) non-endoscopic therapy otherwise. Two separate cohorts will be identified; (1) patients with an endoscopic surveillance history at the moment of study inclusion; and (2) patients with newly diagnosed NDBE at the moment of study inclusion. The primary endpoint will be evaluated separately in both cohorts. The power calculation will be based on the primary endpoint evaluation only in cohort 2, since cohort 1 is prone to selection bias. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This registry that evaluates outcomes of regular clinical care, imposes minimal burden on participants. Subjects are not exposed to procedures or interventions. Data collection is based on existing national databases and medical records. Participants will provide informed consent for inclusion in the database, to ensure that patients understand the study's scope and their rights, with no further obligations for active involvement. Of note, discontinuation of endoscopic surveillance is standard practice according to the guideline. The current studies passively evaluates the outcomes, and patients only provide informed consent for inclusion in the registry. If a patient does not sign the informed consent form, the patient is not included in the registry, still, endoscopic surveillance for this patient will be discontinued. Also robust measures will be implemented to ensure strict adherence to data protection regulations and safeguard participants' privacy and confidentiality. The primary focus remains on upholding ethical standards and minimizing any potential risks to participants while still be able to monitor relevant outcomes