NCT02098863Recruiting
Sickle Cell Clinical Research and Intervention Program
Source: ClinicalTrials.gov · Last updated 4 Jun 2026
Brief summary (registry, in English)
Despite the important work of previous sickle cell disease (SCD) cohort studies, there remain many understudied areas that require investigation. An important knowledge deficit is the slow but progressive process of chronic end-organ dysfunction. The majority of organ dysfunction becomes apparent in the young adult years, but comprehensive assessment of adults and understanding of predictors of adulthood organ dysfunction are insufficient. Similarly, the role of disease-modifying therapies, such as hydroxyurea, in preventing organ dysfunction later in life is not clear. Extended follow-up of patients through the transition into adulthood is imperative to understand the long-term implications of pediatric sickle cell care. This observational study will collect data in a systematic fashion at participants' regular clinic visits (in-person or remote) to answer the objectives described below. In addition to primary study objectives, SCCRIP participants will be eligible to participate in a sub-study, which will investigate genetically determined responses to Hydroxyurea (HU) via a pharmacokinetic study (PK). This one time study will involve blood collection at timed intervals proceeding a dose of HU. Defining the basis for this inter-individual variability will allow the identification of poor HU responders prior to initiation of therapy and the seeking of alternative treatments which seek to optimize disease treatment by accounting for individual variability in genes, environment, and lifestyle.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 21 Mar 2014
- Start date
- 15 Apr 2014
- Primary completion date
- Dec 2044
- Lead sponsor
- St. Jude Children's Research Hospital
- Diseases
- Sickle cell disease
- NCT number
- NCT02098863
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 15 Apr 2014 to the primary completion date, Dec 2044
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Our Lady of the Lake Regional Medical Center Coordinator of this site? Confirm its status | Baton Rouge | United States | Completed |
| Novant Health - Hemby Children's Hospital Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Regional One Health, Diggs-Kraus Sickle Cell Center Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Methodist Adult Comprehensive Sickle Cell Center Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Children's Hospital of Illinois at OSF-Saint Francis Medical Center Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
Related publications
- The Longitudinal Effect of APOL1 Risk Alleles on Sickle Cell Anemia-Associated Kidney Function.Am J Hematol · 2026 · PMID 41870384
This page is information, not medical advice. Discuss any trial with your doctor.