Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-25 @ 5:16 PM
Study NCT ID:
NCT05219903
Status:
RECRUITING
Last Update Posted:
2024-07-25
First Post:
2022-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057765', 'term': 'Eosinophilic Esophagitis'}, {'id': 'C535952', 'term': 'Eosinophilic enteropathy'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D004941', 'term': 'Esophagitis'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004802', 'term': 'Eosinophilia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2022-01-21', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence estimates', 'timeFrame': '5 years', 'description': 'a) To estimate the EGIDs prevalence in patients with gastrointestinal symptoms undergoing upper and lower GI endoscopy, to verify whether the global increase of EGIDs also affects the Italian reality'}, {'measure': 'Incidence estimates', 'timeFrame': '5 years', 'description': 'b) If available the cumulative incidence (new EGIDs cases) may be derived, as a subgroup analysis of the primary endpoint'}, {'measure': 'Prospective epidemiological estimates', 'timeFrame': '5 years', 'description': 'a) To estimate the cumulative incidence of EGIDs (new diagnosis of EGIDs) over the study period.'}], 'secondaryOutcomes': [{'measure': 'Other epidemiological estimates', 'timeFrame': '5 years', 'description': 'a) To compare the cumulative incidence of EGIDs observed in the prospective with the data from the retrospective study (if available) and those available in the literature, to verify the increase of EGIDs, previously observed in a few US observational studies;'}, {'measure': 'Definition of clinical features and potential phenotypes', 'timeFrame': '5 years', 'description': 'b) To describe the clinical characteristics of Italian patients with EGIDs (risk factors, sex, age, comorbidities, response to therapy, natural history), to identify potential phenotypes;'}, {'measure': 'Improvement of diagnostic and therapeutic management', 'timeFrame': '5 years', 'description': 'c) To define shared diagnostic-therapeutic management and verify the adherence of enrolled centers to the international EoE guidelines.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eosinophilic gastrointestinal disorders', 'Children', 'Prevalence', 'Incidence'], 'conditions': ['Eosinophilic Gastrointestinal Disorders', 'Eosinophilic Esophagitis', 'Eosinophilic Gastritis or Gastroenteritis', 'Eosinophilic Colitis']}, 'referencesModule': {'references': [{'pmid': '32061717', 'type': 'BACKGROUND', 'citation': 'Licari A, Votto M, Scudeller L, De Silvestri A, Rebuffi C, Cianferoni A, Marseglia GL. Epidemiology of Nonesophageal Eosinophilic Gastrointestinal Diseases in Symptomatic Patients: A Systematic Review and Meta-Analysis. J Allergy Clin Immunol Pract. 2020 Jun;8(6):1994-2003.e2. doi: 10.1016/j.jaip.2020.01.060. Epub 2020 Feb 28.'}, {'pmid': '31642786', 'type': 'BACKGROUND', 'citation': "Licari A, Votto M, D'Auria E, Castagnoli R, Caimmi SME, Marseglia GL. Eosinophilic Gastrointestinal Diseases in Children: A Practical Review. Curr Pediatr Rev. 2020;16(2):106-114. doi: 10.2174/1573396315666191022154432."}, {'pmid': '32506880', 'type': 'BACKGROUND', 'citation': 'Votto M, Castagnoli R, De Filippo M, Brambilla I, Cuppari C, Marseglia GL, Licari A. Behavioral issues and quality of life in children with eosinophilic esophagitis. Minerva Pediatr. 2020 Oct;72(5):424-432. doi: 10.23736/S0026-4946.20.05913-7. Epub 2020 Jun 4.'}, {'pmid': '32548083', 'type': 'BACKGROUND', 'citation': 'Votto M, Marseglia GL, De Filippo M, Brambilla I, Caimmi SME, Licari A. Early Life Risk Factors in Pediatric EoE: Could We Prevent This Modern Disease? Front Pediatr. 2020 May 29;8:263. doi: 10.3389/fped.2020.00263. eCollection 2020.'}, {'pmid': '33396413', 'type': 'BACKGROUND', 'citation': 'Votto M, De Filippo M, Olivero F, Raffaele A, Cereda E, De Amici M, Testa G, Marseglia GL, Licari A. Malnutrition in Eosinophilic Gastrointestinal Disorders. Nutrients. 2020 Dec 31;13(1):128. doi: 10.3390/nu13010128.'}, {'pmid': '34274254', 'type': 'BACKGROUND', 'citation': 'Votto M, Raffaele A, De Filippo M, Caimmi S, Brunero M, Riccipetitoni G, Marseglia GL, Licari A. Eosinophilic gastrointestinal disorders in children and adolescents: A single-center experience. Dig Liver Dis. 2022 Feb;54(2):214-220. doi: 10.1016/j.dld.2021.06.027. Epub 2021 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'Eosinophilic gastrointestinal disorders (EGIDs) are a heterogeneous group of emerging chronic inflammatory diseases that may affect different gastrointestinal (GI) tracts. Based on the anatomical site involved, EGIDs are distinguished into eosinophilic esophagitis (EoE) and non-esophageal forms, which are subdivided into eosinophilic gastritis (EoG), gastroenteritis (EoGE), and colitis (EoC). EoE is considered the prototype of EGIDs. Since the first description of a case series of patients with EoE, fundamental scientific advances have been achieved, culminating in the redaction of international diagnostic and therapeutic guidelines. In contrast to EoE, non-esophageal forms of EGIDs are still a clinical enigma with evidence limited to a few retrospective studies. In the last decade, an increase in the prevalence of EGIDs has been observed in the pediatric age. Unfortunately, the epidemiology of EGIDs in Italy is still inconsistent and clear estimates are not available.\n\nFirstly, this study will allow us to assess and clarify several clinical and epidemiological aspects of pediatric EGIDs, in particular:\n\n1. prevalence and incidence of pediatric EGIDs in Italy,\n2. the clinical features and potential phenotypes of pediatric EGIDs with potential impact on therapy and management,\n3. diagnostic work-up and adherence to the EoE international guidelines to improve the management, quality of care, and quality of life of affected patients.\n\nThis study has no ethical problems since EoE patients are treated according to international guidelines and those with non-esophageal EGIDs according to the latest scientific evidence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'EoE and EGIDs Definition: Based on current international guidelines, EoE diagnosis requires the presence of more than 15 eos/HPF in endoscopically obtained esophageal biopsies.5 In contrast, the diagnosis of non-esophageal EGIDs should meet the following criteria:\n\n* Chronic/recurrent GI symptoms unresponsive to standard therapies,\n* A prevalent eosinophilic intestinal inflammation,\n* Exclusion of secondary causes of intestinal eosinophilia (e.g., intestinal parasitosis, chronic inflammatory bowel disease, vasculitis, autoimmune diseases, graft versus host disease, tumors).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- All EGIDs patients aged 0-18 years and followed at the centers involved in the study will be considered eligible. Informed consent must be obtained from each enrolled patient and signed by a parent/legal guardian and patient (when older than six years).\n\nExclusion Criteria:\n\n\\- This study will not include patients with:\n\n1. a diagnosis of EGIDs made more than five years before the study participation;\n2. a diagnosis of EoE not in line with current international guidelines;\n3. a secondary cause of intestinal eosinophilic inflammation (inflammatory bowel diseases, autoimmune diseases, vasculitis, graft versus host disease, malignancies).'}, 'identificationModule': {'nctId': 'NCT05219903', 'acronym': 'GOLDEN', 'briefTitle': 'National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}, 'officialTitle': 'National, Multicenter, Retrospective, Prospective Study to Evaluate Pediatric Gastrointestinal Eosinophilic Disorders', 'orgStudyIdInfo': {'id': 'GOLDEN'}}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Amelia Licari, MD', 'role': 'CONTACT', 'email': 'a.licari@smatteo.pv.it', 'phone': '+390382502629'}, {'name': 'Martina Votto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Amelia Licari, MD', 'role': 'CONTACT', 'email': 'a.licari@smatteo.pv.it', 'phone': '+390382502629'}, {'name': 'Martina Votto, MD, PhD', 'role': 'CONTACT', 'email': 'martinavotto@gmail.com', 'phone': '+390382502629'}], 'overallOfficials': [{'name': 'Amelia Licari, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'IRCCS Policlinico San Matteo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Italian Society of Pediatric Allergy & Immunology - Pediatric Centers', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amelia Licari', 'investigatorAffiliation': 'Fondazione IRCCS Policlinico San Matteo di Pavia'}}}}