EoEBiobank: San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology

Sponsor

IRCCS San Raffaele (Other)

Overall Status

Withdrawn

CT.gov ID

NCT05896891

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eosinophilic Esophagitis	Diagnostic Test: esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal

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 anaonymus 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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biobanca San Raffaele EoE: Nuovi Orizzonti Sull'Eziopatogenesi e la Fisiopatologia

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Outcome Measures

Primary Outcome Measures

Molecular characterization of eosinophilic esophagitis [June 1st 2023 to Juune 1 st 2026]
Transcriptomic, metatranscriptomic and molecular staining of different biologic tissues of EoE patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

EoE diagnosis proven histologically with clinical activity
Age > 16 years

Exclusion Criteria:

Not signed informed consent
No definite EoE diagnosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IRCCS San Raffaele Hospital	Milan	Milano	Italy	20132

Sponsors and Collaborators

IRCCS San Raffaele

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Silvio Danese, Professor, IRCCS San Raffaele

ClinicalTrials.gov Identifier:

NCT05896891

Other Study ID Numbers:

EoE Biobank

First Posted:

Jun 9, 2023

Last Update Posted:

Jun 9, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Silvio Danese, Professor, IRCCS San Raffaele

eosinophilic

disorders

translational

Additional relevant MeSH terms:

Esophagitis

Eosinophilic Esophagitis

Study Results

No Results Posted as of Jun 9, 2023