NCT06944067 Study to Understand the Genetic Risk of Developing an Immune Response After Blood Transfusions Among Individuals With Sickle Cell Disease
| NCT ID | NCT06944067 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Human Genome Research Institute (NHGRI) |
| Condition | Sickle Cell Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-24 |
| Primary Completion | 2030-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-24 with a primary completion date of 2030-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
* INCLUSION CRITERIA To be eligible to participate in this study, an individual must meet all of the following 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 An individual who meets any the following criteria will be excluded from participation in this study: 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
Contact & Investigator
Neil A Hanchard, M.D.
PRINCIPAL INVESTIGATOR
National Human Genome Research Institute (NHGRI)
Frequently Asked Questions
Who can join the NCT06944067 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 99 Years, studying Sickle Cell Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06944067 currently recruiting?
Yes, NCT06944067 is actively recruiting participants. Contact the research team at SCDtransfusionstudy@mail.nih.gov for enrollment information.
Where is the NCT06944067 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06944067 clinical trial?
NCT06944067 is sponsored by National Human Genome Research Institute (NHGRI). The principal investigator is Neil A Hanchard, M.D. at National Human Genome Research Institute (NHGRI). The trial plans to enroll 50 participants.
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