San Raffaele EoE Biobank

NCT05896891 | Not Yet Recruiting

• 1 other identifier: EoE Biobank
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Eosinophilic Esophagitis

Keywords

eosinophilic; disorders; translational

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Every male or female patient \> 16 years pertaining to IRCCS San Raffaele Hospital in Milan

You may qualify if:

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

You may not qualify if:

• Not signed informed consent
• No definite EoE diagnosis

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele Hospital

Milan, Milano, 20132, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva and esophageal tissues

MeSH Terms

Conditions

Eosinophilic Esophagitis; Disease

Interventions

Endoscopy, Digestive System

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: June 9, 2023
• Study Start: September 12, 2023
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)