Observational program for sickle cell disease management and outcomes
Official title: Sickle Cell Clinical Research and Intervention Program
Run by St. Jude Children's Research Hospital · NCT02098863 · Data updated 2026-11-12
This study is tracking people with sickle cell disease from childhood to adulthood to see how their condition changes over time and how treatments like hydroxyurea affect their health.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 10000 (estimated) |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Locations | 6 sites (Peoria, Illinois and 5 other locations) |
| Status | Recruiting |
| Started | April 15, 2014 |
| Main results expected | December 2044 |
| Study ends | December 2044 |
| Registry record updated | June 4, 2026 |
| Trial ID | NCT02098863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with sickle cell disease of any genotype, particularly those transitioning from pediatric to adult care.
✕Probably not a fit
Patients with medical or social conditions that would make participation ill-advised, or those unable to complete required procedures, may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational program aims to systematically collect data on individuals with sickle cell disease (SCD) from birth to end of life, focusing on the progression of chronic end-organ dysfunction and the impact of disease-modifying therapies like hydroxyurea. Participants will be followed through their transition from pediatric to adult care at designated centers in Memphis, TN, and affiliated locations. The study will involve regular clinic visits, both in-person and remote, to monitor disease progression and complications. By understanding the long-term implications of pediatric sickle cell care, the program seeks to fill critical knowledge gaps in SCD management.
Why it matters
Potential benefit: If successful, this program could lead to improved management strategies and better long-term outcomes for patients with sickle cell disease.
How similar studies have gone: Previous studies on sickle cell disease have shown success in understanding disease progression and treatment impacts, making this approach a continuation of established research.
Who can join: the full rules
Show full inclusion / exclusion criteria
SCCRIP Inclusion Criteria: * A diagnosis of sickle cell disease of any genotype. * PK Sub-study Inclusion Criteria: * Participants at St. Jude Children's Research Hospital who are consented to the parent protocol (SCCRIP, Amendment 6.1 or above). * Participants currently completing a hydroxyurea (HU) regimen, who have achieved maximum tolerated dose and have maintained that dose for a minimum of 90 days prior to enrollment. SCCRIP Exclusion Criteria: * Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised. * PK Sub-study Exclusion Criteria: * Participants unable to complete the blood draws required for PK sampling. * Inability or unwillingness of research participant or legal guardian/representative to give written informed consent. * Any medical or social reason, which, in the opinion of the principal investigators would make the participation of the subject ill-advised.
Where it's running
-
Children's Hospital of Illinois at OSF-Saint Francis Medical Center
Peoria, Illinois, United States Recruiting -
Novant Health Hemby Children's Hospital
Charlotte, North Carolina, United States Recruiting -
Regional One Health, Diggs-Kraus Sickle Cell Center
Memphis, Tennessee, United States Recruiting -
Methodist Adult Comprehensive Sickle Cell Center
Memphis, Tennessee, United States Recruiting -
St. Jude Children's Research Hospital
Memphis, Tennessee, United States Recruiting -
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States Completed
Study contacts
- Principal investigator: Deepa Manwani, MD — St. Jude Children's Research Hospital
- Study coordinator: Deepa Manwani, MD
- Email: referralinfo@stjude.org
- Phone: 888-226-4343
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients
This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.
-
Adapting and testing PEN-Plus in Zambian primary care
Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.
-
Newborn Sickle Cell Screening in Mozambique
We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.
-
Optimizing Hydroxyurea in Children with Sickle Cell in Africa
This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.
-
Hematopoietic stem cell editing to treat sickle cell disease
This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.
-
Virtual reality options to help with VOC pain in adults with SCD
This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.