Sickle Cell Clinical Research and Intervention Program
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|ClinicalTrials.gov Identifier: NCT02098863|
Recruitment Status : Recruiting
First Posted : March 28, 2014
Last Update Posted : May 11, 2020
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 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.
|Condition or disease|
|Sickle Cell Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||10000 participants|
|Target Follow-Up Duration:||99 Years|
|Official Title:||Sickle Cell Clinical Research and Intervention Program|
|Actual Study Start Date :||April 15, 2014|
|Estimated Primary Completion Date :||December 2044|
|Estimated Study Completion Date :||December 2044|
- Relationship between treatment plan and health outcomes in participants with sickle cell disease (SCD) [ Time Frame: Every 2 years from newborn to ≤ 30 years of age, and every 6 years after age 30 until end-of-life, up until December 2044 ]As described in the Detailed Description, standard of care data will be collected from participants every two years during participants' annual clinic visits until study participation is discontinued or until participants reach death/end of life, whichever occurs last. This collection of observational data will be entered into a study database and will serve as a research resource to facilitate evaluation of health outcomes in participants with SCD from pediatric care into adulthood.
- Relationship between genetic properties of biological samples and health outcomes in participants with sickle cell disease [ Time Frame: Collected every 6 years from newborn until end-of life, up until December 2044 ]A repository of biological samples from participants with sickle cell disease will be established for future retrospective studies investigating genetic and epigenetic contributions to disease severity, response to treatment, and morbidity and mortality.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098863
|Contact: Jane Hankins, MD, MSfirstname.lastname@example.org|
|United States, Illinois|
|Children's Hospital of Illinois at OSF-Saint Francis Medical Center||Recruiting|
|Peoria, Illinois, United States, 61637|
|Contact: Kay Saving, MD 309-624-4945|
|Principal Investigator: Kay Saving, MD|
|United States, Louisiana|
|Our Lady of the Lake Regional Medical Center||Suspended|
|Baton Rouge, Louisiana, United States, 70808|
|United States, North Carolina|
|Novant Health Hemby Children's Hospital||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Paulette Bryant, MD 704-384-1900|
|Principal Investigator: Paulette Bryant, MD|
|United States, Tennessee|
|Regional One Health, Diggs-Kraus Sickle Cell Center||Withdrawn|
|Memphis, Tennessee, United States, 38103|
|Methodist Adult Comprehensive Sickle Cell Center||Recruiting|
|Memphis, Tennessee, United States, 38104|
|Contact: Artangela D. Henry, DNP, AFNP 901-516-8182|
|Principal Investigator: Kenneth Ataga, MBBS|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Jane Hankins, MD, MS 866-278-5833 email@example.com|
|Principal Investigator: Jane Hankins, MD, MS|
|Principal Investigator:||Jane Hankins, MD, MS||St. Jude Children's Research Hospital|