Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT00588718
Status:
UNKNOWN
Last Update Posted:
2018-03-09
First Post:
2008-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Biologic Validation of Biomarkers of Progressive NEC & Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], 'ancestors': [{'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and Urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 740}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-03-08', 'studyFirstSubmitDate': '2008-01-03', 'studyFirstSubmitQcDate': '2008-01-03', 'lastUpdatePostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-01-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To verify the diagnostic and prognostic biomarker panels with sufficiently powered new cohorts.', 'timeFrame': '4 years', 'description': 'Study has been amended/extended. Test the NEC diagnostic panel for its ability to distinguish NEC from SIP. Develop validated biomarkers on biosensors in preparation for prospective validation studies.\n\nIndependent prospective validation of biosensor based biomarker panels.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Necrotizing enterocolitis', 'Progressive necrotizing enterocolitis', 'Proteomics in blood', 'Genomics in blood', 'Multi-center'], 'conditions': ['Necrotizing Enterocolitis']}, 'referencesModule': {'references': [{'pmid': '18784730', 'type': 'RESULT', 'citation': 'Moss RL, Kalish LA, Duggan C, Johnston P, Brandt ML, Dunn JC, Ehrenkranz RA, Jaksic T, Nobuhara K, Simpson BJ, McCarthy MC, Sylvester KG. Clinical parameters do not adequately predict outcome in necrotizing enterocolitis: a multi-institutional study. J Perinatol. 2008 Oct;28(10):665-74. doi: 10.1038/jp.2008.119. Epub 2008 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Necrotizing enterocolitis (NEC) is a severe, sometimes life-threatening inflammation of the intestine that occurs most often in premature babies. If it progresses, the wall of the intestine may perforate, spilling bacteria and stool into the abdomen. Parts or all of the intestine may die. Despite 30 years of clinical studies, the cause of NEC remains unknown.\n\nIn this study, we will be conducting an independent case-control validation study to verify the diagnostic and prognostic biomarker panels, develop validated biomarkers on boisensors in preparation for prospective validation studies, and conduct independent prospective validation of biosensor based biomarker panels on clinical samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Weeks', 'minimumAge': '72 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Prematurely-born infants with with suspected necrotizing enterocolitis, sepsis or SIP who meet study entry criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria - NEC/Sepsis Cohort GA \\< 29 weeks Current age equal or \\<12 weeks Suspicion of NEC or Sepsis\n\nExclusion - NEC/Sepsis Cohort Current or prior diagnosis of NEC Early onset infection (equal or \\<72 hours of life) Previous diagnosis of sepsis within 7 days Previous abdominal surgery Significant congenital anomaly\n\nInclusion Criteria - SIP Cohort Infants born at \\<29 weeks gestation Equal to or \\<12 weeks of age at the time of eligibility assessment a decision to perform surgery (or drain) for suspected NEC or SIP\n\nExclusion - SIP Cohort Congenital infection (Equal to \\<72 hours of life) Prior episode of NEC or SIP Prior laparotomy or drain for SIP or NEC'}, 'identificationModule': {'nctId': 'NCT00588718', 'acronym': 'NEC', 'briefTitle': 'A Biologic Validation of Biomarkers of Progressive NEC & Sepsis', 'organization': {'class': 'OTHER', 'fullName': "Nationwide Children's Hospital"}, 'officialTitle': 'A Biologic Sample Study for the Validation of Biomarkers of Progressive NEC & Sepsis', 'orgStudyIdInfo': {'id': '26128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Infants who meet the entry criteria'}, {'label': 'Controls', 'description': 'Banked blood samples from newborns who do not meet inclusion criteria for this study will be held at Stanford University Core Laboratory and will constitute controls. Proteomic and genomic profiles in blood samples of cases will be compared with blood samples of controls.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "R. Lawrence Moss, MD, Nationwide Children's Hospital, The Ohio State University, Karl Sylvester, MD, Stanford University, Stanford, Califorinia", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'R. Lawrence Moss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nationwide Children's Hospital, The Ohio State University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R. Lawrence Moss', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mallinckrodt', 'class': 'INDUSTRY'}, {'name': 'Stanford University', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Pennsylvania', 'class': 'OTHER'}, {'name': 'Yale University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Surgeon In Chief', 'investigatorFullName': 'R. Lawrence Moss', 'investigatorAffiliation': "Nationwide Children's Hospital"}}}}