Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-02-22 @ 8:13 PM
Study NCT ID:
NCT03581695
Status:
UNKNOWN
Last Update Posted:
2022-05-19
First Post:
2018-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inflammatory Biomarkers of Pediatric Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006403', 'term': 'Hematologic Tests'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2018-06-20', 'studyFirstSubmitQcDate': '2018-06-26', 'lastUpdatePostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of HGMB1', 'timeFrame': '1 day', 'description': 'Measurement of HGMB1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension, Pulmonary']}, 'descriptionModule': {'briefSummary': 'To investigate if the inflammatory protein, high mobility group box 1 (HMGB1), along with other inflammatory mediators, is elevated in pediatric patients with congenital heart disease (CHD) and pulmonary hypertension as compared to those with CHD alone, or with healthy controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of any age coming for cardiac catheterization and healthy controls coming for urology surgery.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-patients of any age with congenital cardiac disease coming for catheterization of the right heart, or both the right and left heart.\n\nExclusion Criteria:\n\n* active systemic infection\n* current active cancer\n* active cancer treatment\n* prior bone marrow transplant\n* prior solid organ transplant'}, 'identificationModule': {'nctId': 'NCT03581695', 'briefTitle': 'Inflammatory Biomarkers of Pediatric Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Inflammatory Biomarkers of Pediatric Pulmonary Hypertension: a Prospective Cohort Study', 'orgStudyIdInfo': {'id': '1000058900'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Hypertension and Congenital Heart Disease', 'description': 'Pulmonary Hypertension and Congenital Heart Disease', 'interventionNames': ['Other: Blood test']}, {'label': 'Congenital Heart Disease', 'description': 'Congenital Heart Disease', 'interventionNames': ['Other: Blood test']}, {'label': 'Healthy Controls', 'description': 'Healthy Controls', 'interventionNames': ['Other: Blood test']}], 'interventions': [{'name': 'Blood test', 'type': 'OTHER', 'description': 'Blood test', 'armGroupLabels': ['Congenital Heart Disease', 'Healthy Controls', 'Pulmonary Hypertension and Congenital Heart Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Katherine Taylor', 'role': 'CONTACT', 'email': 'katherine.taylor@sickkids.ca', 'phone': '4168138921'}], 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Katherine Taylor, MD', 'role': 'CONTACT', 'email': 'katherine.taylor@sickkids.ca', 'phone': '4168138921'}, {'name': 'Neil Goldenberg, MD PhD', 'role': 'CONTACT', 'email': 'neil.goldenberg@sickkids.ca', 'phone': '4168137445'}, {'name': 'Benjamin Steinberg, MD PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Katherine Taylor', 'role': 'CONTACT', 'email': 'katherine.taylor@sickkids.ca', 'phone': '4168137445'}], 'overallOfficials': [{'name': 'Katherine Taylor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Hospital for Sick Children'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Staff Anesthesiologist', 'investigatorFullName': 'Katherine Taylor', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}