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

National Alliance for Sickle Cell Centers1,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Sickle Cell Trait

Interventions

Biologic Specimen CollectionOTHER

Participants will have blood and urine collected at Baseline

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Adults ages 18 and older 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

Locations (10)

University of Alabama

Birmingham, Alabama, United States

RECRUITING

Loma Linda University Health Care

Loma Linda, California, United States

RECRUITING

Outcomes

Primary Outcomes

Hemoglobin variant quantification

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)

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

Secondary Outcomes

Red blood cell rheology

Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters

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

Natural History

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

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

Central Contacts

Julie Kanter, MD

CONTACT

(202) 596-1548 jkanter@sicklecellcenters.org

Data from ClinicalTrials.gov

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