Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
ConditionSickle Cell Trait
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational Alliance for Sickle Cell Centers
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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 population
Adults aged 18 and older with sickle cell trait.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Biologic Specimen Collection
Other interventionParticipants will have blood and urine collected at Baseline
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Individuals with sickle cell trait1 intervention
Trial outcomes
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 yearsSecondary 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 years2
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Alliance for Sickle Cell Centers
Lead sponsor
Beam Therapeutics Inc.
Collaborator
Source ClinicalTrials.gov