Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease
NCT ID: NCT06944067
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
50 participants
OBSERVATIONAL
2025-06-24
2030-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
NCT03405402
Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
NCT03288012
Risk Factors for Allo-immunization in Sickle Cell Disease
NCT03401125
Prophylactic Transfusion In Pregnant in Women With Sickle Cell Disease
NCT06979492
A Gene Transfer Study Inducing Fetal Hemoglobin in Sickle Cell Disease (GRASP, BMT CTN 2001)
NCT05353647
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This 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.
Objectives:
Primary Objective:
Elucidate the role of previously identified risk loci in the development of alloantibodies among individuals with SCD.
Secondary Objective:
Validate and characterize additional, novel alloimmunization-related candidate loci.
Endpoints:
Primary Endpoint:
Completion of analysis of previously identified risk loci to determine the relationship between genome structure and expression.
Secondary Endpoint:
No additional candidate loci from concurrent discovery studies to evaluate.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alloimmune non-responders
Individuals with sickle cell disease who have received blood transfusions but never had an alloimmune response to transfusion.
No interventions assigned to this group
Alloimmune responders
Individuals with sickle cell disease who have a history of an alloimmune response when receiving blood transfusions.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1\. Individual (\> 2 years of age) with confirmed SCD diagnosis who meets at least one of the following conditions:
1. History of greater than ten administered transfusions or 20 transfusion units (where known)
2. History of one or more antibody screens
3. Known candidate variant genotype
Exclusion Criteria
1. Impaired decision-making capability, with or without a legally authorized representative
2. History of transplant (e.g., organ, bone marrow, stem cell)
3. Taking immunosuppressive medications at time of enrollment
4. Confirmed pregnancy
2 Years
99 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Human Genome Research Institute (NHGRI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil A Hanchard, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Human Genome Research Institute (NHGRI)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
NIH Clinical Center Office of Patient Recruitment (OPR)
Role: primary
Related Links
Access external resources that provide additional context or updates about the study.
NIH Clinical Center Detailed Web Page
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
002264-HG
Identifier Type: -
Identifier Source: secondary_id
10002264
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.