Sickle Cell TraitNCT06071377
Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
An observational study of Sickle Cell Trait, run by National Alliance for Sickle Cell Centers at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Trait
- What is being tested?
- Biologic Specimen Collection
- How many people
- 1,000 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Apr 2023to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 18 and older with sickle cell trait.
Who may be able to join
- 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
Who cannot join
- Unwilling to sign consent
- Known end-stage renal disease or dialysis
- Known SCD (including sickle cell-beta thalassemia)
- People who do not have SCT
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
University of Alabama
Birmingham, Alabama, 35294
Marteesa William Oliver, marteesawilliams@uabmc.edu
Julie Kanter
- Recruiting
University of North Carolina
Chapel Hill, North Carolina, 27599
David Wichlan, david_wichlan@med.unc.edu
Patrick Ellison
- Recruiting
Functional Fluidics
Detroit, Michigan, 48202
Jennell White, PhD, jennell.white@functionalfluidics.com
Ifeoma Iwuagwu, ifeoma.iwuagwu@functionalfluidics.com
- Recruiting
Duke University
Durham, North Carolina, 27710
Morgan Low, morgan.low@duke.edu
JJ Strouse, MD
- Recruiting
East Carolina University
Greenville, North Carolina, 27834
Chloe Wilde, wildec26@ecu.edu
Beng Fuh
- Recruiting
UT Health Houston
Houston, Texas, 77030
Amanda Gregg, amanda.gregg@uth.tmc.edu
Idowu Modupe, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Claire Kendrick, cjkendri@iu.edu
Andrew O'Brien
- Recruiting
Nemours Children's Hospital
Wilmington, Delaware, 19803
Nicole Wittmeyer, Nicole.Wittmeyer@nemours.org
Robin Miller, MD
About this study
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.
- Conditions
- Sickle Cell Trait
- Being tested
- Biologic Specimen Collection
- Medical subject headings
- Sickle Cell Trait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biologic Specimen CollectionOther
Participants will have blood and urine collected at Baseline
| Study group | Role | What they receive |
|---|---|---|
| Individuals with sickle cell trait | Not described Receives: Other: Biologic Specimen Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Red blood cell rheology
Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters
Measured: Through study completion, an average of 2 years
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
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Apr 2023
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell TraitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Alliance for Sickle Cell Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Beam Therapeutics Inc.
- Responsible party
- Sponsor
- Investigators
- Julie Kanter, MD, Principal investigator, National Alliance for Sickle Cell Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071377
- Sponsor's protocol ID
- AUNT
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2023
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
- ClinicalTrials.gov ID
- NCT06071377
- Acronym / sponsor ID
- AUNT
- Conditions
- Sickle Cell Trait
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- National Alliance for Sickle Cell CentersUniversity, hospital or other
- Collaborators
- Beam Therapeutics Inc.
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with sickle cell trait | – | Other: Biologic Specimen Collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 and older with sickle cell trait.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Unwilling to sign consent
- Known end-stage renal disease or dialysis
- Known SCD (including sickle cell-beta thalassemia)
- People who do not have SCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biologic Specimen CollectionParticipants will have blood and urine collected at Baseline | Other | Individuals with sickle cell trait |
Primary outcome
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)
2 secondary outcomes
Red blood cell rheology
Time frame: Through study completion, an average of 2 years
Natural History
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julie Kanter, MD principal investigator
National Alliance for Sickle Cell Centers
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Trait, run by National Alliance for Sickle Cell Centers at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Kanter, MD ((202) 596-1548, jkanter@sicklecellcenters.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin variant quantification (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.