Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)

National Alliance for Sickle Cell Centers10 sites in 1 country1,000 target enrollmentApril 1, 2023

ConditionsSickle Cell Trait

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sickle Cell Trait
Sponsor: National Alliance for Sickle Cell Centers
Enrollment: 1000
Locations: 10
Primary Endpoint: Hemoglobin variant quantification
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main purpose of this study is to create a longitudinal cohort of those with Sickle Cell Trait (SCT) to better understand the hematologic phenotype for those that carry HbS, assess for differences in those with varying quantities of HbS and assess for potential clinical complications of SCT.

Registry

clinicaltrials.gov

Start Date

April 1, 2023

End Date

February 1, 2027

Last Updated

5 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

National Alliance for Sickle Cell Centers

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Are willing to voluntarily participate and sign the study consent
•Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status
•Adults ages 18 and older

Exclusion Criteria

•Unwilling to sign consent
•Known end-stage renal disease or dialysis
•Known SCD (including sickle cell-beta thalassemia)
•People who do not have SCT

Outcomes

Primary Outcomes

Hemoglobin variant quantification

Time Frame: Through study completion, an average of 2 years

Determine range of variability in baseline %HbS in SCT subjects and relationship of baseline %HbS to markers of hemolysis (LDH, reticulocytes, haptoglobin), coagulopathy (D-dimer), and renal disease (urine albumin/creatinine ratio)