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:
National Human Genome Research Institute (NHGRI)
Organization:
Study Overview
Official Title:
Observational Study to Determine Red Blood Cell Alloimmunization Risk Etiology in Patients With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2025-05-20
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Study Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 002264-HG | None | None | View |