Sickle Cell Clinical Research and Intervention Program

Part of paid clinical trials in Peoria, Illinois.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT02098863
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Apr 15, 2014
Status verified
Jun 2026
Primary completion
Dec 31, 2044
Completion
Dec 31, 2044

Study Design

Enrollment
10,000 participants (estimated)

Primary Outcome Measure

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 ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Children's Hospital of Illinois at OSF-Saint Francis Medical CenterPeoriaIllinois61637
Kay Saving, MD
309-624-4945
Kay Saving, MD (PRINCIPAL_INVESTIGATOR)
Our Lady of the Lake Regional Medical CenterBaton RougeLouisiana70808-
Novant Health Hemby Children's HospitalCharlotteNorth Carolina28204
Felipe Bautista Otanez, MD
704-384-1900
Felipe B. Otanez, MD (PRINCIPAL_INVESTIGATOR)
Methodist Adult Comprehensive Sickle Cell CenterMemphisTennessee38104
Marquita D. Nelson, MD
901-516-8182
Kenneth Ataga, MD (PRINCIPAL_INVESTIGATOR)
Regional One Health, Diggs-Kraus Sickle Cell CenterMemphisTennessee38103
Ugochi Ogu, MD
901-545-8535
Kenneth Ataga, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Deepa Manwani, MD
[email protected]
888-226-4343
Deepa Manwani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Peoria, IL

By condition
Sickle cell disease
By research site
Children's Hospital of Illinois at OSF-Saint Francis Medical Center· Peoria, ILOur Lady of the Lake Regional Medical Center· Baton Rouge, LANovant Health Hemby Children's Hospital· Charlotte, NCMethodist Adult Comprehensive Sickle Cell Center· Memphis, TNRegional One Health, Diggs-Kraus Sickle Cell Center· Memphis, TNSt. Jude Children's Research Hospital· Memphis, TN

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