NCT06443346

Brief Summary

This is a prospective registry of all the Eosinophilic Esophagitis (EoE) patients referred to the third level referral centre of San Raffaele Scientific Institute

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
224mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jun 2024Dec 2044

First Submitted

Initial submission to the registry

May 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 5, 2024

Completed
10.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2034

Expected
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2044

Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

10.6 years

First QC Date

May 30, 2024

Last Update Submit

July 28, 2025

Conditions

Eosinophilic Esophagitis

Outcome Measures

Primary Outcomes (1)

  • The prospective collection of histologic, endoscopic and clinical data on EoE patients

    10 years

Interventions

Eosinophilic EsophagitisOTHER

Eosinophilic Esophagitis patients with a proper diagnosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

EoE patients with a definite diagnosis according to the recent guidelines: \>15 eos HPF as peak eosinophils count in at least 1 esophageal location in presence of symptoms of esophageal disfunction, undergoing various treatment and subsequent follow-up visits and endoscopies

You may qualify if:

  • Participant is willing and able to give informed consent for participation in the study.
  • The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice
  • Being diagnosed with EoE as per guidelines of the disease

You may not qualify if:

  • No clear diagnosis of EoE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Related Publications (7)

  • Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.

    PMID: 26488694BACKGROUND

  • Arias A, Perez-Martinez I, Tenias JM, Lucendo AJ. Systematic review with meta-analysis: the incidence and prevalence of eosinophilic oesophagitis in children and adults in population-based studies. Aliment Pharmacol Ther. 2016 Jan;43(1):3-15. doi: 10.1111/apt.13441. Epub 2015 Oct 28.

    PMID: 26510832BACKGROUND

  • Mansoor E, Cooper GS. The 2010-2015 Prevalence of Eosinophilic Esophagitis in the USA: A Population-Based Study. Dig Dis Sci. 2016 Oct;61(10):2928-2934. doi: 10.1007/s10620-016-4204-4. Epub 2016 Jun 1.

    PMID: 27250980BACKGROUND

  • Dellon ES, Peery AF, Shaheen NJ, Morgan DR, Hurrell JM, Lash RH, Genta RM. Inverse association of esophageal eosinophilia with Helicobacter pylori based on analysis of a US pathology database. Gastroenterology. 2011 Nov;141(5):1586-92. doi: 10.1053/j.gastro.2011.06.081. Epub 2011 Jul 14.

    PMID: 21762663BACKGROUND

  • Kottyan LC, Davis BP, Sherrill JD, Liu K, Rochman M, Kaufman K, Weirauch MT, Vaughn S, Lazaro S, Rupert AM, Kohram M, Stucke EM, Kemme KA, Magnusen A, He H, Dexheimer P, Chehade M, Wood RA, Pesek RD, Vickery BP, Fleischer DM, Lindbad R, Sampson HA, Mukkada VA, Putnam PE, Abonia JP, Martin LJ, Harley JB, Rothenberg ME. Genome-wide association analysis of eosinophilic esophagitis provides insight into the tissue specificity of this allergic disease. Nat Genet. 2014 Aug;46(8):895-900. doi: 10.1038/ng.3033. Epub 2014 Jul 13.

    PMID: 25017104BACKGROUND

  • Ma C, Schoepfer AM, Safroneeva E; COREOS Collaborators; COREOS Collaborators. Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus. Gastroenterology. 2021 Sep;161(3):748-755. doi: 10.1053/j.gastro.2021.04.080. Epub 2021 May 20. No abstract available.

    PMID: 34022180BACKGROUND

  • Hahn JW, Lee K, Shin JI, Cho SH, Turner S, Shin JU, Yeniova AO, Koyanagi A, Jacob L, Smith L, Fond G, Boyer L, Lee SW, Kwon R, Kim S, Shin YH, Rhee SY, Moon JS, Ko JS, Yon DK, Papadopoulos NG. Global Incidence and Prevalence of Eosinophilic Esophagitis, 1976-2022: A Systematic Review and Meta-analysis. Clin Gastroenterol Hepatol. 2023 Dec;21(13):3270-3284.e77. doi: 10.1016/j.cgh.2023.06.005. Epub 2023 Jun 17.

    PMID: 37331411BACKGROUND

MeSH Terms

Conditions

Eosinophilic Esophagitis

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Alberto Barchi, MD

CONTACT

3348630784barchi.alberto@hsr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 30, 2024

First Posted

June 5, 2024

Study Start

June 1, 2024

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 31, 2044

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)