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Recruiting

NCT Number: NCT06071377

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

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.

Recruiting

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Key information

Conditions

Sickle Cell Trait Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biologic Specimen Collection

Other

Participants will have blood and urine collected at Baseline

Primary outcomes

  1. 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)

Secondary outcomes

  1. Red blood cell rheology

    Time frame: 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

  2. Natural History

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Kanter, MD

CONTACT

[email protected]

(202) 596-1548

Sponsors and collaborators

Lead sponsor

National Alliance for Sickle Cell Centers

Other

Collaborators

  • Beam Therapeutics Inc.

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 6, 2023
Registry last updated
Nov 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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