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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06071377

Enrollment

1000

Registered

2023-10-06

Start date

2023-04-01

Completion date

2027-02-28

Last updated

2025-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Trait

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.

Interventions

OTHERBiologic Specimen Collection

Participants will have blood and urine collected at Baseline

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Contacts

Primary ContactJulie Kanter, MD

jkanter@sicklecellcenters.org(202) 596-1548

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026