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Recruiting NCT06071377

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

Observational Sickle Cell Trait

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Biologic Specimen Collection.
Who it may be relevant to
Registry conditions: Sickle Cell Trait. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Biologic Specimen Collection
    Participants will have blood and urine collected at Baseline

Primary outcome measures

  • Hemoglobin variant quantification [Time frame: Through study completion, an average of 2 years]
Secondary outcome measures (2)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 10 centers
  • University of Alabama — Birmingham
  • Loma Linda University Health Care — Loma Linda
  • Nemours Children's Hospital — Wilmington
  • Indiana University — Indianapolis
  • Functional Fluidics — Detroit
  • University of North Carolina — Chapel Hill
  • Duke University — Durham
  • East Carolina University — Greenville
  • … and 2 more centers

Identifiers

NCT: NCT06071377 · AUNT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗