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NCT05896891 Clinical Trial

San Raffaele EoE Biobank

Eosinophilic Esophagitis Clinical Trial

— EoEBiobank  

Official title:
San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05896891
Other study ID # EoE Biobank
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 12, 2023
Est. completion date June 1, 2026

Study information
Verified date August 2023
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 500
Est. completion date June 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Months and older
Eligibility Inclusion Criteria: - EoE diagnosis proven histologically with clinical activity - Age > 16 years Exclusion Criteria: - Not signed informed consent - No definite EoE diagnosis

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal
During routine EGD, biopsy, blood and buccal saliva samples will be withdraw and stored at San Raffaele Hospital

Locations
Country Name City State
Italy IRCCS San Raffaele Hospital Milan Milano

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Molecular characterization of eosinophilic esophagitis Transcriptomic, meta-transcriptomic and molecular staining of different biologic tissues of EoE patients June 1st 2023 to June 1 st 2026
See also
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Recruiting NCT02331849 - Esophageal Motility in Eosinophilic Esophagitis Evaluated by High Resolution Manometry. N/A
Active, not recruiting NCT02202590 - Using Spectrally Encoded Confocal Microscopy (SECM) to Image the Esophagus N/A
Active, not recruiting NCT05176249 - Prospective Database for Eosinophilic Esophagitis (EoE) of Pediatric Population
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Terminated NCT01404832 - The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors Phase 4