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

• Sponsor: National Alliance for Sickle Cell Centers (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06071377
• Collaborator: Beam Therapeutics Inc. (Industry)
• Enrollment: 1,000
• Locations: 6
• Anticipated Duration (Months): 24
• Patients Per Site: 166.7
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Trait	Other: Biologic Specimen Collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Achieving Understanding of the Natural History of Sickle Cell Trait (AUNT)
• Actual Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Individuals with sickle cell trait	Other: Biologic Specimen Collection; Participants will have blood and urine collected annually at Baseline, Year 1 and Year 2.

Outcome Measures

Primary Outcome Measures

1. Hemoglobin variant quantification [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)

Secondary Outcome Measures

1. Red blood cell rheology [Through study completion, an average of 2 years]

   Identify range of variation in baseline RBC rheological parameters in SCT subjects and relationship to %HbS, other baseline clinical parameters

2. Natural History [Through study completion, an average of 2 years]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Loma Linda University Health Care	Loma Linda	California	United States	92354
3	Indiana University	Indianapolis	Indiana	United States	46202
4	Johns Hopkins University	Baltimore	Maryland	United States	21224
5	University of North Carolina	Chapel Hill	North Carolina	United States	27599
6	East Carolina University	Greenville	North Carolina	United States	27834

Sponsors and Collaborators

• National Alliance for Sickle Cell Centers
• Beam Therapeutics Inc.

Investigators

• Principal Investigator: Julie Kanter, MD, National Alliance for Sickle Cell Centers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Alliance for Sickle Cell Centers
• ClinicalTrials.gov Identifier: NCT06071377
• Other Study ID Numbers: AUNT
• First Posted: Oct 6, 2023
• Last Update Posted: Oct 6, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sickle Cell Trait

Study Results

No Results Posted as of Oct 6, 2023