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NCT06443346 Clinical Trial

Prospective Registry of EoSinophilic esOphagitis

Eosinophilic Esophagitis Clinical Trial

— PRESO  

Official title:
Prospective Registry of EoSinophilic esOphagitis (PRESO)

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06443346
Other study ID # PRESO
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date December 31, 2044

Study information
Verified date June 2024
Source IRCCS San Raffaele
Contact Alberto Barchi, MD
Phone +393348630784
Email barchi.alberto@hsr.it
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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

Description:

Primary objective of the study is to create a registry of all EoE patients with > 18 years of age referring to the Motility and EoE Unit of San Raffaele Hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2044
Est. primary completion date December 31, 2034
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Participant is willing and able to give informed consent for participation in the study. 2. The medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice 3. Being diagnosed with EoE as per guidelines of the disease Exclusion Criteria: 1. No clear diagnosis of EoE 2. Not willing to provide informed consent to the inclusion in the registry

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Eosinophilic Esophagitis
Eosinophilic Esophagitis patients with a proper diagnosis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary The prospective collection of histologic, endoscopic and clinical data on EoE patients 10 years
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