Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05153967 · ClinicalTrials.gov registry record
Cooperative Assessment of Late Effects for SCD Curative Therapies
A clinical trial of Sickle Cell Disease and Heart Disease, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- 750
- Enrollment target
- 5
- Study locations
NCT05153967: Recruiting study of Sickle Cell Disease and Heart Disease, sponsored by Vanderbilt University Medical Center.
NCT05153967 is a study of Sickle Cell Disease and Heart Disease that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 750 participants, above the 289-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (160% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05153967, a study of Sickle Cell Disease and Heart Disease, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- 750 participants
- Enrollment target
- 5
- Study locations
Study Summary
Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \>99% of those born in high resource settings, including the United States, France, and England, now surviving to 18 years of age. However, the life expectancy of adults with SCD is severely shortened. Dysfunction of the heart, lung, and kidney is directly associated with decreased life expectancy. With the variety of curative therapies that are now available for SCD, long-term health outcomes studies are time-sensitive. As of now, efforts to determine long-term health outcomes following curative therapies for SCD have been limited. Though curative therapies initially should provide a cure for symptoms of SCD, there is the risk of late health outcomes to consider. Defining health outcomes following curative therapy is essential to improve personalized decision-making when considering curative versus disease-modifying therapeutic options. The primary goal of this study is to determine whether curative therapies for individuals with SCD will result in improved or worsening heart, lung, and kidney damage when compared to individuals with SCD receiving standard therapy. The investigators will also explore whether certain genes are associated with a good or bad outcome after curative therapy for SCD.
Primary Outcome
Measurements of forced expiratory volume in 1 second (FEV1) based on the global lung index will be acquired from children with SCD receiving myeloablative curative therapies and adults with SCD receiving nonmyeloablative allo-HSCT, as well as from the respective control children and adult cohorts with SCD who received standard therapy. FEV1 will be reported in liters. (References: Eur Respir J. Volume 40 Issue 6: pages 1324-1343, 2012 June 27; Am J Hematol. Volume 93 Issue 3: pages 408-415, 2018
Conditions Studied
Study Locations (5)
Maryland
- Johns Hopkins Hospital - Baltimore
- National Institutes of Health Clinical Center - Bethesda
District of Columbia
- Children's National Medical Center - Washington D.C.
Georgia
- Emory University School of Medicine - Atlanta
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 750 participants |
| Start Date | 2022-07-12 |
| Est. Completion | 2027-02 |
What NCT05153967 shows while recruiting
NCT05153967 is an observational study that tracks outcomes without assigning an intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, above the 289-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (160% higher).
The record links to 4 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 0 interventions.
NCT05153967 lists 5 locations in 4 states (Maryland, District of Columbia, Georgia).
Frequently Asked Questions
What is clinical trial NCT05153967 about?
NCT05153967 is a clinical study titled "Cooperative Assessment of Late Effects for SCD Curative Therapies". Sickle Cell Disease is one of the most common genetic diseases in the United States, occurring in approximately 1 in 400 births. Approximately 100,000 individuals are diagnosed with SCD in the United States. Mortality for children with SCD has decreased substantially over the past 4 decades, with \>...
What is the current status of trial NCT05153967?
This trial is currently recruiting. The enrollment target is 750 participants. The study started on 2022-07-12. Estimated completion is 2027-02.
What conditions does trial NCT05153967 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Heart Disease, Pulmonary Disease, Renal Disease.
Who is sponsoring clinical trial NCT05153967?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05153967 being conducted?
This trial has 5 study locations across District of Columbia, Georgia, Maryland, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sickle Cell Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05153967's enrollment target sits among peer trials
750 4th of 213 higher than 210 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Sub-dissociative Dose Ketamine in Treatment of Vaso-occlusive Pain Event in Children and Young Adults
RECRUITING · Phase 2
-
Early Life Exposures Among Children With Sickle Cell Disease
RECRUITING · NA
-
Exercise in Child Health
RECRUITING · NA
-
Sickle Cell Children's Exercise Study (SuCCESs)
RECRUITING · NA
-
Study of Panobinostat (LBH589) in Patients With Sickle Cell Disease
RECRUITING · Phase 1
-
Hematopoietic Stem Cell BCL11A Enhancer Gene Editing for Severe β-Hemoglobinopathies
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02048332 · 750 participants · Phase 1
Donor-Derived Viral Specific T-cells (VSTs)
- NCT02087852 · 750 participants
Kidney Cancer DNA Registry
- NCT02532452 · 750 participants · Phase 2
Third Party Viral Specific T-cells (VSTs)
- NCT03126916 · 750 participants · Phase 3
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI