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

November 4, 2025 updated by: National Alliance for Sickle Cell Centers
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama
        • Principal Investigator:
          • Julie Kanter
        • Contact:
    • California
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Health Care
        • Contact:
        • Principal Investigator:
          • Akshat Jain
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Nemours Children's Hospital
        • Principal Investigator:
          • Robin Miller, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Andrew O'Brien
        • Contact:
    • Michigan
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
        • Principal Investigator:
          • Patrick Ellison
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Principal Investigator:
          • JJ Strouse, MD
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Beng Fuh
        • Contact:
    • Ohio
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT Health Houston
        • Contact:
        • Principal Investigator:
          • Idowu Modupe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults aged 18 and older with sickle cell trait.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Individuals with sickle cell trait
Other: Biologic Specimen Collection
Participants will have blood and urine collected at Baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 2 years
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
Through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Alliance for Sickle Cell Centers

Collaborators

Beam Therapeutics Inc.

Investigators

  • Principal Investigator: Julie Kanter, MD, National Alliance for Sickle Cell Centers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

October 4, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Estimated)

November 6, 2025

Last Update Submitted That Met QC Criteria

November 4, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUNT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe