An observational study in Eosinophilic Esophagitis, sponsored by IRCCS San Raffaele. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by IRCCS San Raffaele · Observational
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Among 21 studies in Eosinophilic Esophagitis with a site in Italy — 8 open to participants now, 11 under way, 1 of them phase 3. Eosinophilic Esophagitis · Italy.
Among the 21 studies in Eosinophilic Esophagitis with a site in Italy, this one is the 7th largest by planned enrollment of the 12 observational ones that give a count, is one of 5 that started in 2023, is one of 12 observational ones, reaches primary completion later than 0 of the 10 other live ones, and was the 15th registered.
235 studies on the registry are indexed under Eosinophilic Esophagitis; 53 are open to participants now.
Browse Eosinophilic Esophagitis studies →8 of the 21 studies in Eosinophilic Esophagitis with a site in Italy are open now. Recruiting first, the newest first:
IRCCS San Raffaele · Sites in Italy
Ages 18+ · Healthy volunteers
Fondazione IRCCS Policlinico San Matteo di Pavia · Sites in Italy
Ages 5+
IRCCS San Raffaele · Sites in Italy
Federico II University · Sites in Italy
Ages 3–65
Fondazione IRCCS Policlinico San Matteo di Pavia · Sites in Italy
Ages 0–18
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 42 Eosinophilic Esophagitis studies recruiting now, 12 (29%) set no upper age limit and 27 (64%) stop at 75 or younger; 27 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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21 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 5 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 105 is above the median of 88 across 85 observational studies indexed under Eosinophilic Esophagitis.
Median enrollment 211 across the 9 interventional studies, 153 across the 12 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
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8 of 21 have an industry lead sponsor. The 10 most frequent:
IRCCS San Raffaele is the lead sponsor of 454 studies on the registry; 235 are open to participants now.
IRCCS San Raffaele has 5 studies filed under Eosinophilic Esophagitis — fewer than ten, so there is no comparison to draw.
3 of the studies in Eosinophilic Esophagitis with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05219903Fondazione IRCCS Policlinico San Matteo di PaviaNational, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders | 2027-01-31 |
| NCT06598462Uniquity One (UNI)A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis | 2027-04-30 |
| NCT07708467Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in Eosinophilic Esophagitis | 2027-08-01 |
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Among the 21 studies in Eosinophilic Esophagitis with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a retrospective monocentric observational study involving patients with Eosinophilic esophagitis (EoE), gastroesophageal reflux disease (GERD), and controls (patients without EoE and GERD). To validate the EoE-related markers obtained with the EoE TaMMA web app (such as CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA, CXCL12, ACVRL1, POSTN, and LTBP4), we will stain and analyze EoE, GERD, and controls Formalin-fixed paraffin-embedded (FFPE) tissue samples already stored in the pathological laboratory of OSR. For this reason, this project will be accomplished thanks to the collaboration with prof.
Doglioni's team at OSR.
Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory disease, primarily activated by food antigens, with the concomitant accumulation of eosinophils within the esophageal mucosal layer where the Th2-response-specific interleukin (IL) 5 and IL13 play a key role during its pathogenesis. EoE positions as an uncommon disease, with a suggested genetic basis and a 3:1 male preponderance. Its incidence rate varies between 0.1 and 1.2 cases per 10,0009 and increases annually. EoE symptoms include difficulty with eating, failure to thrive, vomiting, chest and/or abdominal pain, dysphagia, and food impaction, histologically associated with esophageal linear furrows with loss of vascularity, mucosal rings, a small-caliber lumen, strictures, mucosal exudates, and, less commonly, polyps and ulcerations. The currently adopted therapies are mainly based on proton pump inhibition, topical administration of glucocorticoids, and changes in dietary habits. However, in most patients, eosinophilic esophagitis remains a chronic disease, and if treatment is stopped, inflammation ensues and symptoms recur. This may hamper the quality of life, including vitality and general health scores, and complications may develop. Therefore, the complete comprehension of the mechanisms occurring during EoE pathogenesis remains of paramount importance to implementing and improving the therapeutic lines of intervention, ameliorating the overall patients' wellness.
A straightforward and facilitated EoE clinical diagnosis is still missing, since EoE provokes in patients symptoms overlapping with other disease manifestations, such as gastroesophageal reflux disease (GERD), eosinophilic gastrointestinal disease, and achalasia. Along with the mucosal immunity alterations, the epithelial barrier function impairment does remain a hallmark of EoE, in terms of both increased permeability and antigen sensing and EoE TaMMA .
Indeed, at the mucosal level, EoE is featured by a striking pattern of dilated interepithelial spaces, with down-regulation of proteins associated with barrier function and adhesion molecules, in turn, modulated via an IL13-dependent mechanism. As a consequence, altered epithelial permeability can lead to a permissive environment that enhances antigen presentation, which in turn leads to persistent chronic inflammation.
Despite some anatomical and molecular characterizations employed as a kind of gold standard for the definition of the EoE pathogenesis, a meta-analysis of the molecular studies may improve the understanding of the physiopathology of the disease and define molecular markers helpful for a straightforward diagnosis of EoE has not been performed yet. We recently developed and released the Inflammatory Bowel Disease (IBD) Transcriptome and Metatranscriptome Meta-Analysis web app (IBD TaMMA, https://ibd-meta-analysis.herokuapp.com/), a complete survey of all public data sets generated for IBD-related studies. TaMMA has contributed to the field of omics data meta-analysis by providing an open source framework that will enable the community to easily access, query, and 'play' with the data through a user-friendly web application and offering an unprecedented opportunity to define new hypotheses and insights for better understanding the pathogenesis of IBD.
Considering the utility that IBD TaMMA has been increasingly showing over the last months, we developed a similar meta-analysis of EoE-related public data sets visualized in an interactive web app, the EoE TaMMA, that includes studies analyzing EoE, GERD and controls (without EoE and GERD). EoE-related phenotypes were confirmed throughout the web app. To further consolidate the platform, we are proposing the validation of EoE TaMMA results in an independent cohort of EoE and GERD patients, by taking advantage of the EoE and GERD.
We will use FFPE samples derived from patients who, at the time of the endoscopic exam, have signed the informed consent form to authorize the use of their clinical data for scientific purposes.
We will validate the EoE TaMMA results (such as the upregulation of CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA, CXCL12, ACVRL1, POSTN, and LTBP4 in EoE tissues by comparison with the GERD and the controls (without EoE and GERD)) by analyzing the EoE, GERD and controls FFPE samples already stored in the pathological laboratory.
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.
FFPE tissue samples patients who:
Exclusion Criteria:
FFPE tissues from patients who:
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis
Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis
Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis
We will stain and analyze EoE, GERD, and controls Formalin-fixed paraffin-embedded (FFPE) tissue samples already stored in the pathological laboratory of OSR.
To evaluate the presence and the expression of several markers, including CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA, CXCL12, ACVRL1, POSTN, and LTBP4 in FFPE tissue samples.
The investigators will use FFPE samples derived from patients who, at the time of the endoscopic exam, have signed the informed consent form to authorize the use of their clinical data for scientific purposes. The investigators will stain FFPE tissue samples with specific immunohistochemical antibodies, quantifying the presence of these specific markers: CCL26, TBX5, NOX4, FGF7, CXCL14, ADAMTS5, PDGFRA,CXCL12, ACVRL1, POSTN, and LTBP4. In order to perform the standard staining procedure, first the tissue section has to be deparaffinized and then rehydrated before applying the primary antibody. Enzyme-conjugated secondary antibodies are then applied, and the specific staining can be visualized after adding the enzyme- specific substrate.
Time frame: 1-12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2023; primary completion for Nov 2024, 12 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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