Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
1 other identifier
observational
1,000
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2023
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 26, 2023
CompletedFirst Posted
Study publicly available on registry
October 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
November 6, 2025
November 1, 2025
3.7 years
September 26, 2023
November 4, 2025
Conditions
Outcome Measures
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)
Through study completion, an average of 2 years
Secondary Outcomes (2)
Red blood cell rheology
Through study completion, an average of 2 years
Natural History
Through study completion, an average of 2 years
Study Arms (1)
Individuals with sickle cell trait
Interventions
Participants will have blood and urine collected at Baseline
Eligibility Criteria
Adults aged 18 and older with sickle cell trait.
You may qualify if:
- 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
You may not qualify if:
- Unwilling to sign consent
- Known end-stage renal disease or dialysis
- Known SCD (including sickle cell-beta thalassemia)
- People who do not have SCT
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Alliance for Sickle Cell Centerslead
- Beam Therapeutics Inc.collaborator
Study Sites (10)
University of Alabama
Birmingham, Alabama, 35294, United States
Loma Linda University Health Care
Loma Linda, California, 92354, United States
Nemours Children's Hospital
Wilmington, Delaware, 19803, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Functional Fluidics
Detroit, Michigan, 48202, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
UT Health Houston
Houston, Texas, 77030, United States
Biospecimen
For individuals who consent to provide optional DNA testing, an alpha globin sequencing (ATHAL) test will be included.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie Kanter, MD
National Alliance for Sickle Cell Centers
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 6, 2023
Study Start
April 1, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
February 1, 2027
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share