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San Raffaele EoE Biobank

San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05896891
Acronym
EoEBiobank
Enrollment
500
Registered
2023-06-09
Start date
2023-09-12
Completion date
2026-06-01
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic, disorders, translational

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

Interventions

DIAGNOSTIC_TESTesophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal

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

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* EoE diagnosis proven histologically with clinical activity * Age \> 16 years

Exclusion criteria

* Not signed informed consent * No definite EoE diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Molecular characterization of eosinophilic esophagitisJune 1st 2023 to June 1 st 2026Transcriptomic, meta-transcriptomic and molecular staining of different biologic tissues of EoE patients

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026