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

Sickle Cell Trait Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06071377
• Other study ID #: AUNT
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 2025

Study information

• Verified date: October 2023
• Source: National Alliance for Sickle Cell Centers
• Contact: Julie Kanter, MD
• Phone: (202) 596-1548
• Email: jkanter[@]sicklecellcenters.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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. Be willing and able to participate in the 2- year study plan.

4. Adults ages 18-65

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

Related Conditions & MeSH terms

• Sickle Cell Trait

Intervention

Other:
• Biologic Specimen Collection
Participants will have blood and urine collected annually at Baseline, Year 1 and Year 2.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	East Carolina University	Greenville	North Carolina
United States	Indiana University	Indianapolis	Indiana
United States	Loma Linda University Health Care	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
National Alliance for Sickle Cell Centers	Beam Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Red blood cell rheology	Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters	Through study completion, an average of 2 years
Secondary	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	Through study completion, an average of 2 years