Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT03288012
Status:
UNKNOWN
Last Update Posted:
2019-07-19
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples for DNA analysis and analysis of immune system components involved in alloimmune reactions following erythrocyte transfusion'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-17', 'studyFirstSubmitDate': '2017-09-13', 'studyFirstSubmitQcDate': '2017-09-15', 'lastUpdatePostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion', 'timeFrame': '6 months', 'description': 'Multiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alloimmunization', 'Sickle Cell Disease']}, 'descriptionModule': {'briefSummary': 'The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.', 'detailedDescription': 'The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients.\n\nSubjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion).\n\nAt each time point specific markers of the immune system will be measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Sickle cell disease population receiving care in the participating hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sickle cell disease\n* Receiving a red blood cell transfusion\n\nExclusion Criteria:\n\n* Previous positive screen for allo-antibodies\n* \\>25 red blood cell units in the past'}, 'identificationModule': {'nctId': 'NCT03288012', 'acronym': 'STARRING', 'briefTitle': 'Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics', 'organization': {'class': 'OTHER', 'fullName': 'Sanquin Research & Blood Bank Divisions'}, 'officialTitle': 'Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics', 'orgStudyIdInfo': {'id': 'NL60834.018.17'}}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam-Zuidoost', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Karin Fijnvandraat, PhD', 'role': 'CONTACT', 'email': 'c.j.fijnvandraat@amc.nl', 'phone': '+31 02 5123122'}], 'facility': 'Academic Medical Center Amsterdam', 'geoPoint': {'lat': 52.3075, 'lon': 4.97222}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'S Schols, MD', 'role': 'CONTACT', 'phone': '0031243618800'}], 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marjon Cnossen, PhD', 'role': 'CONTACT'}, {'name': 'Marjon Cnossen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'status': 'NOT_YET_RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jean Louis Kerkhoffs, PhD', 'role': 'CONTACT'}, {'name': 'Jean-Louis Kerkhoffs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HagaZiekenhuis', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}], 'centralContacts': [{'name': 'Karin Fijnvandraat, MD PhD', 'role': 'CONTACT', 'email': 'k.fijnvandraat@sanquin.nl', 'phone': '+31205123122'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanquin Research & Blood Bank Divisions', 'class': 'OTHER'}, 'collaborators': [{'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'HagaZiekenhuis', 'class': 'OTHER'}, {'name': 'Erasmus Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}