An observational study in Eosinophilic Esophagitis, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Months and older. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by IRCCS San Raffaele · Observational
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.
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
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
This study's planned enrollment of 500 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Browse Eosinophilic Esophagitis studies →IRCCS San Raffaele is the lead sponsor of 453 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Every male or female patient > 16 years pertaining to IRCCS San Raffaele Hospital in Milan
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During routine EGD, biopsy, blood and buccal saliva samples will be withdraw and stored at San Raffaele Hospital
Molecular characterization of eosinophilic esophagitis
Transcriptomic, meta-transcriptomic and molecular staining of different biologic tissues of EoE patients
Time frame: June 1st 2023 to June 1 st 2026
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2023; primary completion for Jun 2026, 32 months later.
Of 52 non-industry observational studies under Eosinophilic Esophagitis, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 120. This study's planned 32 months is below that.
Counting every sponsor, half of 55 studies reached it within 49 months; a quarter within 22 and three quarters within 120.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.