Eosinophilic EsophagitisEoEBiobankNCT05896891
San Raffaele EoE Biobank
An observational study of Eosinophilic Esophagitis, run by IRCCS San Raffaele at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Eosinophilic Esophagitis
- What is being tested?
- esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 12 Sep 2023to 1 Jun 2026
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Every male or female patient > 16 years pertaining to IRCCS San Raffaele Hospital in Milan
Who may be able to join
- EoE diagnosis proven histologically with clinical activity
- Age > 16 years
Who cannot join
- Not signed informed consent
- No definite EoE diagnosis
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS San Raffaele Hospital
Milan, Milano, 20132
Alberto Barchi, MD, 3348630784, albertobarchi34@gmail.com
Silvio Danese, PhD, barchi.alberto@hsr.it
About this study
Official title: San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology
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.
Read the 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
- Conditions
- Eosinophilic Esophagitis
- Being tested
- esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawal
- Keywords
- eosinophilic, disorders, translational
- Medical subject headings
- Eosinophilic Esophagitis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawalDiagnostic test
During routine EGD, biopsy, blood and buccal saliva samples will be withdraw and stored at San Raffaele Hospital
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular characterization of eosinophilic esophagitis
Transcriptomic, meta-transcriptomic and molecular staining of different biologic tissues of EoE patients
Measured: June 1st 2023 to June 1 st 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start12 Sep 2023 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eosinophilic EsophagitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvio Danese, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05896891
- Sponsor's protocol ID
- EoE Biobank
- Acronym
- EoEBiobank
- Status last verified
- Aug 2023
- First submitted
- 31 May 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San Raffaele EoE Biobank: New Horizons From Etiopathogenesis and Physiopathology
- ClinicalTrials.gov ID
- NCT05896891
- Acronym / sponsor ID
- EoEBiobank / EoE Biobank
- Conditions
- Eosinophilic Esophagitis
- Keywords
- eosinophilic, disorders, translational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 12 Sep 2023 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Every male or female patient > 16 years pertaining to IRCCS San Raffaele Hospital in Milan
Key inclusion criteria (2 listed)
- EoE diagnosis proven histologically with clinical activity
- Age > 16 years
Key exclusion criteria (2 listed)
- Not signed informed consent
- No definite EoE diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| esophagogastroduodenoscopy (EGD), buccal swab, blood withdrawalDuring routine EGD, biopsy, blood and buccal saliva samples will be withdraw and stored at San Raffaele Hospital | Diagnostic test | – |
Primary outcome
Molecular characterization of eosinophilic esophagitis
Time frame: June 1st 2023 to June 1 st 2026
Transcriptomic, meta-transcriptomic and molecular staining of different biologic tissues of EoE patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eosinophilic Esophagitis, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular characterization of eosinophilic esophagitis (time frame: June 1st 2023 to June 1 st 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.