Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT04549727
Status:
UNKNOWN
Last Update Posted:
2020-09-17
First Post:
2020-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-02-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-15', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparative studies of gene expression', 'timeFrame': '2 years', 'description': "assess the gene expression profile of tissue, epithelial enteroids and underlying lamina propria derived from NEC, non-NEC (further classified as hypoxic and non-hypoxic infants).\n\nNB: the unit of analysis will be the organoids derived from patients' tissues Investigators expect to be able to derive 1 cell line per patient, and the number of derived organoids will depend from the viability of individual cell lines."}, {'measure': 'functional studies barrier functionality', 'timeFrame': '2 years', 'description': 'evaluation of barrier functionality at the baseline and in enteroids-derived monolayers challenged with pathogens, dead bacteria (as postbiotics), LPS, pharmacological agents, enteral nutrients and to evaluate innate immune response and barrier functionality as previously investigated in fetal enteroids and the contribution of myofibroblast, immune and ENS to the immune response'}, {'measure': 'functional studies on cellular death', 'timeFrame': '2 years', 'description': 'studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions'}, {'measure': 'Correlative studies of the impact of perinatal variables', 'timeFrame': '2 years', 'description': 'Assess how the perinatal features (expression of the neonatal phenotype, as IUGR, chorionamnionitis, perinatal hypoxia) on the intestinal barrier functionality at baseline and challenged with pathogens'}, {'measure': 'compare the intestinal barrier functionality in pathological conditions', 'timeFrame': '2 years', 'description': 'comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants'}, {'measure': 'Validation of the enteroid NEC model', 'timeFrame': '2 years', 'description': 'Validate the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Enterocolitis, Necrotizing', 'Prematurity', 'Gastrointestinal Disease']}, 'descriptionModule': {'briefSummary': 'Despite a greater understanding of NEC physiopathology, modest progress has been done in terms of intervention and prevention of the disease over the past three decades, being the mortality rate unchanged.\n\nInvestigators intend to leverage our knowledge and technical expertise developed with fetal enteroids to further investigate the processes leading to NEC by deriving and performing functional studies on human intestinal enteroids generated from intestinal resection for therapeutic reasons in NEC and non-NEC patients\n\n1. Generate a tissue biorepository composed of: enteroids and other lamina propria cells\n2. Comparative studies of the gene expression profile of tissue, epithelial enteroids and underlying lamina propria of NEC, non-NEC, hypoxic and non-hypoxic infants\n3. In vitro functional studies for the evaluation of critical factors in NEC pathophysiology\n4. In vitro functional studies to identify the activation of processes leading to intestinal epithelium necroptosis and/or apoptosis in bacteria challenged and hypoxic conditions\n5. Correlative studies of the impact of perinatal variables on the intestinal barrier functionality at baseline and challenged with pathogens\n6. In vitro comparison of the intestinal barrier functionality in infants complicated by condition of prenatal hypoxia versus non hypoxic infants\n7. Validation the NEC enteroids as an in vitro model for the identification of treatments and prevention of NEC'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '44 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Investigators will use surgically-resected intestinal samples from NEC patients and gestational age-matched non-NEC surgical controls with intestinal resection for other reasons than NEC to conduct various analysis. For comparative studies, Investigators aim to grow enteroids from intestinal tissues freshly collected from preterm and term babies with an age limit of 44 weeks of postmenstrual age (PMA).\n\nGroup 1: intestinal samples from small and/or large bowel in NEC preterm and term babies.\n\nGroup 2 (Control group): Age- and intestinal area-matched (small and/or large bowel) No NEC babies, which have surgical resection for other reason than NEC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants, with a postconceptional age below 44 weeks of gestation, undergoing a clinically indicated intervention of partial intestinal resection while hospitalized at the NICU of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico.\n\nExclusion Criteria:\n\n* Infants presenting a devastating damage of the intestine'}, 'identificationModule': {'nctId': 'NCT04549727', 'briefTitle': 'Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of NEC', 'organization': {'class': 'OTHER', 'fullName': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}, 'officialTitle': 'Development and Use of a Tissue and Human Enteroid Biorepository to Study the Pathophysiology of Neonatal Necrotizing Enterocolitis', 'orgStudyIdInfo': {'id': 'BIENTERNIP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'infants with surgical NEC', 'description': 'Infants who undergo surgery for NEC disease', 'interventionNames': ['Other: Organoids creation']}, {'label': 'Infants with GI surgical diseases other than NEC', 'description': 'Infants who undergo surgery for other GI diseases than NEC', 'interventionNames': ['Other: Organoids creation']}], 'interventions': [{'name': 'Organoids creation', 'type': 'OTHER', 'description': 'Organoids are created from discarded tissue', 'armGroupLabels': ['Infants with GI surgical diseases other than NEC', 'infants with surgical NEC']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Paola Roggero, MD PHD', 'role': 'CONTACT', 'email': 'paola.roggero@unimi.it', 'phone': '+393472777054'}, {'name': 'valentina bozzetti, md phd', 'role': 'CONTACT', 'email': 'vbozzetti@hotmail.com', 'phone': '+18573138200'}], 'overallOfficials': [{'name': 'Paola Roggero, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Milan Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico", 'class': 'OTHER'}, 'collaborators': [{'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}