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

Recruiting

• Conditions: Sickle Cell Trait
• Interventions: Other: Biologic Specimen Collection

• Registration Number: NCT06071377
• Lead Sponsor: National Alliance for Sickle Cell Centers

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Study First Submitted: 2023-09-26
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Are willing to voluntarily participate and sign the study consent
2. Know/suspect they have SCT and are willing to get tested to confirm/learn about their SCT status
3. Be willing and able to participate in the 2- year study plan.
4. Adults ages 18-65

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with sickle cell trait	Biologic Specimen Collection	-

Primary Outcome Measures

Name	Time	Method
Hemoglobin variant quantification	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)

Secondary Outcome Measures

Name	Time	Method
Red blood cell rheology	Through study completion, an average of 2 years	Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters
Natural History	Through study completion, an average of 2 years	Evaluate the frequency of hemolysis; * Evaluate potential for and progression of chronic kidney disease and albuminuria; * Evaluate the relative risk of thrombosis based on medical history; * Evaluate the prevalence of episodes of pain or exercise-related symptoms

Trial Locations

Locations (9)

Nemours Children's Hospital; 🇺🇸 Wilmington, Delaware, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States

University of Alabama; 🇺🇸 Birmingham, Alabama, United States

Loma Linda University Health Care; 🇺🇸 Loma Linda, California, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

East Carolina University; 🇺🇸 Greenville, North Carolina, United States