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Sickle Cell Clinical Research and Intervention Program

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
No age limits stated
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study follows people with any type of sickle cell disease to learn how the disease and its treatments affect organs over time. It collects information during regular clinic visits, in person or remotely. An added study looks at how genes affect the body's response to hydroxyurea, a sickle cell medicine.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Main study: You have sickle cell disease of any type.
  • Added study: You receive care at St. Jude Children's Research Hospital and have agreed to join the required version of the main study.
  • Added study: You take hydroxyurea at the highest dose you can tolerate and have stayed on that dose for at least 90 days before joining.

Who can't join

  • Either study: The study leaders believe a medical or social reason makes joining unwise for you.
  • Added study: You cannot complete the required blood draws.
  • Added study: You or your legal guardian or representative cannot or will not give written permission to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (6)

IL

  • Children's Hospital of Illinois at OSF-Saint Francis Medical Center · Peoria, IL 61637Kay Saving, MD · Study contact · 309-624-4945Kay Saving, MD · Principal investigatorMore trials in Peoria

LA

NC

  • Novant Health Hemby Children's Hospital · Charlotte, NC 28204Felipe Bautista Otanez, MD · Study contact · 704-384-1900Felipe B. Otanez, MD · Principal investigatorMore trials in Charlotte

TN