Monocentric Retrospective Observational Study for Validation of Meta-analysis of the Metatrascryptome and Transcriptome of Eosynophyl Esophagitis

NCT06071585 | Unknown

• 1 other identifier: EoE TaMMA
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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. Doglioni's team at OSR.

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

• 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.

  1-12 months

Study Arms (3)

patients with Eosinophilic esophagitis (EoE)

Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis

patients with gastroesophageal reflux disease (GERD)

Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis

controls (patients without EoE e GERD)

Other: Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis

Interventions

Formalin-fixed Paraffin-embedded (FFPE) tissue samples analysis OTHER

We will stain and analyze EoE, GERD, and controls Formalin-fixed paraffin-embedded (FFPE) tissue samples already stored in the pathological laboratory of OSR.

controls (patients without EoE e GERD); patients with Eosinophilic esophagitis (EoE); patients with gastroesophageal reflux disease (GERD)

Eligibility Criteria

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

Study Population

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.

You may qualify if:

• FFPE tissue samples patients who:
• had previously undergone endoscopic biopsy-collection in the clinical unit of Gastroenterology and Digestive Endoscopy according to the clinical practice (from 31/07/2012 to 31/07/2022)
• during that endoscopic biopsy-collection they already signed the attestation of will for using their clinical data for future scientific studies

You may not qualify if:

• FFPE tissues from patients who:
• \- have not signed the attestation of will for authorized using the use of their clinical data for future scientific studies.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, Italy

Location

MeSH Terms

Conditions

Eosinophilic Esophagitis

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

Central Study Contacts

Federica Ungaro

CONTACT

0226437864; ungaro-federica@hsr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Gastroenterology and Endoscopy Unit

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 6, 2023
• Study Start: November 1, 2023
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-10

Locations

IT (1)