Clinical trial NCT06443346: Prospective Registry of EoSinophilic esOphagitis
Official title: Prospective Registry of EoSinophilic esOphagitis (PRESO)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Eosinophilic Esophagitis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The prospective collection of histologic, endoscopic and clinical data on EoE patients
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Furuta GT, Katzka DA. Eosinophilic Esophagitis. N Engl J Med. 2015 Oct 22;373(17):1640-8. doi: 10.1056/NEJMra1502863.
citation: 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.
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.
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.
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.
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.
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.