Recruiting

Genetic Risk

Sponsor:

National Human Genome Research Institute (NHGRI)

Code:

NCT06944067

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT06944067

Start date

Jun 24, 2025

Status verified date

Sep 1, 2026

Completion date

Apr 10, 2030

Anticipated

Primary completion date

Apr 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 70+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Alloimmune non-responders

Individuals with sickle cell disease who have received blood transfusions but never had an alloimmune response to transfusion.

Alloimmune responders

Individuals with sickle cell disease who have a history of an alloimmune response when receiving blood transfusions.

Primary outcome measure

  • Completion of analysis of previously identified risk loci to determine the relationship between genome structure and expression. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Emilyn C Banfield

(240) 328-0965SCDtransfusionstudy@mail.nih.gov

Neil A Hanchard, M.D.

(301) 594-2151neil.hanchard@nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Human Genome Research Institute (NHGRI)

Last update posted

Sep 3, 2026

Last verified

Sep 1, 2026

Keywords

  • Sickle Cell Disease
  • Transfusion
  • Alloimmunization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Human Genome Research Institute (NHGRI) on 2026-09-03.