Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06944067
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05-20', 'completionDateStruct': {'date': '2030-04-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2025-04-24', 'studyFirstSubmitQcDate': '2025-04-24', 'lastUpdatePostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion of analysis of previously identified risk loci to determine the relationship between genome structure and expression.', 'timeFrame': '5 years', 'description': 'Analyze samples from study participants to determine whether they have the loci we previously identified.'}], 'secondaryOutcomes': [{'measure': 'No additional candidate loci from concurrent discovery studies to evaluate.', 'timeFrame': '5 years', 'description': 'When we can no longer identify new potentially causal loci, the study endpoint will be achieved.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sickle Cell Disease', 'Transfusion', 'Alloimmunization'], 'conditions': ['Sickle Cell Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_002264-HG.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': "The purpose of this research study is to look at genes and determine how they interact with each other to find changes that could explain why some people's immune systems may respond to blood transfusions. This response is called an alloimmune response. We strongly believe that when someone has an alloimmune response, it is caused by changes in their genes. We plan to compare changes in the genes of individuals that develop red blood cell alloimmunization after blood transfusions with those that do not develop alloimmunization. This may help us to create more targeted therapeutic interventions, which may improve the health of alloimmune responders.", 'detailedDescription': 'Study Description:\n\nThis study seeks to fine-map risk variants associated with increased susceptibility to developing red blood cell alloantibodies in patients with sickle cell disease (SCD), with the goal of characterizing the molecular basis of the alloimmunization response. This will allow for improved clinical management for individuals susceptible to alloimmunization responses.\n\nObjectives:\n\nPrimary Objective:\n\nElucidate the role of previously identified risk loci in the development of alloantibodies among individuals with SCD.\n\nSecondary Objective:\n\nValidate and characterize additional, novel alloimmunization-related candidate loci.\n\nEndpoints:\n\nPrimary Endpoint:\n\nCompletion of analysis of previously identified risk loci to determine the relationship between genome structure and expression.\n\nSecondary Endpoint:\n\nNo additional candidate loci from concurrent discovery studies to evaluate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with sickle cell disease who may or may not have had a history of alloimmune response to blood transfusions. The study population will include children ages 2-17 years old and adults. The study population will not include pregnant women, people taking immunosuppressive medications, or people with a history of transplant (e.g., bone marrow or stem cell transplant).', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1\\. Individual (\\> 2 years of age) with confirmed SCD diagnosis who meets at least one of the following conditions:\n\n1. History of greater than ten administered transfusions or 20 transfusion units (where known)\n2. History of one or more antibody screens\n3. Known candidate variant genotype\n\nEXCLUSION CRITERIA\n\nAn individual who meets any the following criteria will be excluded from participation in this study:\n\n1. Impaired decision-making capability, with or without a legally authorized representative\n2. History of transplant (e.g., organ, bone marrow, stem cell)\n3. Taking immunosuppressive medications at time of enrollment\n4. Confirmed pregnancy'}, 'identificationModule': {'nctId': 'NCT06944067', 'briefTitle': 'Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Observational Study to Determine Red Blood Cell Alloimmunization Risk Etiology in Patients With Sickle Cell Disease', 'orgStudyIdInfo': {'id': '10002264'}, 'secondaryIdInfos': [{'id': '002264-HG'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alloimmune non-responders', 'description': 'Individuals with sickle cell disease who have received blood transfusions but never had an alloimmune response to transfusion.'}, {'label': 'Alloimmune responders', 'description': 'Individuals with sickle cell disease who have a history of an alloimmune response when receiving blood transfusions.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'NIH Clinical Center Office of Patient Recruitment (OPR)', 'role': 'CONTACT', 'email': 'ccopr@nih.gov', 'phone': '800-411-1222', 'phoneExt': 'TTY dial 711'}], 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'centralContacts': [{'name': 'Emilyn C Banfield', 'role': 'CONTACT', 'email': 'SCDtransfusionstudy@mail.nih.gov', 'phone': '(240) 328-0965'}, {'name': 'Neil A Hanchard, M.D.', 'role': 'CONTACT', 'email': 'neil.hanchard@nih.gov', 'phone': '(301) 594-2151'}], 'overallOfficials': [{'name': 'Neil A Hanchard, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Human Genome Research Institute (NHGRI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Human Genome Research Institute (NHGRI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}