San Raffaele EoE Biobank

NCT ID: NCT05896891

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-12
• Study Completion Date: 2026-06-01

Brief Summary

Eosinophilic Esophagitis (EoE) is a immuno-mediated disease, characterised by a Th-2 food-antigen driven chronic inflammatory response of the esophagus. Main symptoms are dysphagia and food bolus impaction, frequently overlapping with most atypical and general symptoms like heartburn or regurgitation and difficulty to thrive in children. Overall incidence and prevalence of EoE are rapidly increasing. The complete comprehension of pathogenetic and molecular mechanism underlying this complex and relatively new disease is still to be conquered. For this reason, we created this EoE Biobank, in order to collect blood, oral and esophageal tissue samples of proven EoE patients to further exploit new insights of this disease.

Detailed Description

Every EoE patient pertaining to the EoE Unit of San Raffaele Hospital in Milan from 1st June 2023 will be enrolled in the EoE Biobank protocol after being adequately informed and after having signed the informed consent during a preliminary visit where also different clinical and demographic variable of each patient will be taken and stored in an anonymus database. Every patient, during the endoscopic examination performed according to clinical practice guideline for his management, will be asked to provide a sample of oral saliva, 5 mL of blood sample (directly withdraw from the previously placed venous catheter) and additional esophageal biopsies from the esophagus, normally performed for the diagnosis or the follow-up of the disease. The collected samples will be stored in Biological Resources Centre (BRC) of the host organization. These sample will later be analyzed "in vitro" in the context of dedicated protocols

Conditions

Eosinophilic Esophagitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal

During routine EGD, biopsy, blood and buccal saliva samples will be withdraw and stored at San Raffaele Hospital

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• EoE diagnosis proven histologically with clinical activity
• Age > 16 years

Exclusion Criteria

• Not signed informed consent
• No definite EoE diagnosis

• Minimum Eligible Age: 18 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Silvio Danese

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS San Raffaele Hospital

Milan, Milano, Italy

Countries

Italy

Facility Contacts

Alberto Barchi, MD

Role: primary

albertobarchi34@gmail.com

3348630784

Silvio Danese, PhD

Role: backup

barchi.alberto@hsr.it

Other Identifiers

EoE Biobank

Identifier Type: -

Identifier Source: org_study_id