Ignite Creation Date:
2024-05-06 @ 7:36 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06071585
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-06
First Post:
2023-09-25
Brief Title:
Monocentric Retrospective Observational Study for Validation of Meta-analysis of the Metatrascryptome and Transcriptome of Eosynophyl Esophagitis
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Monocentric Retrospective Observational Study for Validation of Meta-analysis of the Metatrascryptome and Transcriptome of Eosynophyl Esophagitis EoE TaMMA
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Doglionis team at OSR
Doglionis team at OSR
Detailed Description:
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 31 male preponderance Its incidence rate varies between 01 and 12 cases per 100009 and increases annually EoE symptoms include difficulty with eating failure to thrive vomiting chest andor 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 httpsibd-meta-analysisherokuappcom 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
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 httpsibd-meta-analysisherokuappcom 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None