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RecruitingNCT06071377Updated Nov 6, 2025

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

An observational study in Sickle Cell Trait, sponsored by National Alliance for Sickle Cell Centers. Recruiting at 10 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-06.

Sponsored by National Alliance for Sickle Cell Centers · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Sickle Cell Trait

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults aged 18 and older with sickle cell trait.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Individuals with sickle cell trait

    Other: Biologic Specimen Collection

Interventions

  • OtherBiologic Specimen Collection

    Participants will have blood and urine collected at Baseline

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What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

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Study locations

10 of 10 sites recruiting
  • University of Alabama
    Birmingham, Alabama 35294, United States
    Recruiting
  • Loma Linda University Health Care
    Loma Linda, California 92354, United States
    • Monica Pizana · Contact · mpizana@llu.edu
    • Akshat Jain · Principal investigator
    Recruiting
  • Nemours Children's Hospital
    Wilmington, Delaware 19803, United States
    Recruiting
  • Indiana University
    Indianapolis, Indiana 46202, United States
    • Claire Kendrick · Contact · cjkendri@iu.edu
    • Andrew O'Brien · Principal investigator
    Recruiting
  • Functional Fluidics
    Detroit, Michigan 48202, United States
    Recruiting
  • University of North Carolina
    Chapel Hill, North Carolina 27599, United States
    Recruiting
  • Duke University
    Durham, North Carolina 27710, United States
    Recruiting
  • East Carolina University
    Greenville, North Carolina 27834, United States
    Recruiting
  • Nationwide Children's Hospital
    Columbus, Ohio 43205, United States
    Recruiting
  • UT Health Houston
    Houston, Texas 77030, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT06071377
Lead sponsor
National Alliance for Sickle Cell Centers
Collaborators
Beam Therapeutics Inc.
Responsible party
Sponsor
First posted
Oct 6, 2023
Start date
Apr 1, 2023
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Nov 6, 2025

Study contacts

Julie Kanter, MD
Contact
jkanter@sicklecellcenters.org
(202) 596-1548
Julie Kanter, MD
principal investigator · National Alliance for Sickle Cell Centers

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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