A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT01220115
- Lead Sponsor
- Novartis
- Brief Summary
A long term observational study in sickle cell disease will enhance the understanding of the disease patterns, current transfusion practices, treatments and outcomes in sickle cell disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 498
- Male or female patients with HbSS, HbS/beta-thalassemia and HbSC
- Age > 2 years old.
- Written informed consent by the patient or legal guardians, and pediatric assent where indicated.
- Patients with Sickle Cell trait (HbAS) are not eligible for the study
- Patient or legal guardians unable or unwilling to give consent, or pediatric assent where indicated.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Document current treatment patterns, natural history and outcomes in patients with sickle cell disease up to 5 years
- Secondary Outcome Measures
Name Time Method Measure Sickle cell crisis and hospitalizations up to 5 years To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations
Data collection up to 5 years Collection of the following data:Current therapies used for the treatment of SCD Current transfusion practices, Difference in treatments between pediatric and adult patients, Use of chelation therapies, Frequency and types of crises including Frequency of hospitalizations, Incidence of end organ damage (caridac, renal, pulmonary,liver), Quality of life assessed by PedsQL TM Pediatric Quality of Life Inventory for patients 2- \<18 years old and SF-36® Health Survey for patients 18 years old and older
Trial Locations
- Locations (42)
Hematology Oncology, P.C.
🇺🇸Stamford, Connecticut, United States
Children's Hospital Oakland (CHO)
🇺🇸Oakland, California, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Children's Hospital of Orange County Sickle Cell Disease Center
🇺🇸Orange, California, United States
Howard University
🇺🇸Washington, District of Columbia, United States
Broward Oncology Associates, P.A.
🇺🇸Fort Lauderdale, Florida, United States
All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Illinois at Chicago, Dept of Pediatrics
🇺🇸Chicago, Illinois, United States
Abington Hematology Oncology Associates, Inc
🇺🇸Oak Lawn, Illinois, United States
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins University Division of Hematology
🇺🇸Baltimore, Maryland, United States
LSU Department of Pediatrics Children's Hospital
🇺🇸New Orleans, Louisiana, United States
Children's Hospital Boston - Harvard
🇺🇸Boston, Massachusetts, United States
Oncology-Hematology Associates, P.A.
🇺🇸Clinton, Maryland, United States
Boston Comprehensive Sickle Cell Center
🇺🇸Boston, Massachusetts, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
University of Missouri Child Health, Division of Pediatric Hematology/Oncology
🇺🇸Columbia, Missouri, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
New York Methodist Hospital Dept of Med/Sickle Cell Program
🇺🇸Brooklyn, New York, United States
Interfaith Medical Center-Comprehensive Sickle Cell Program
🇺🇸Brooklyn, New York, United States
Presbyterian Hospital Pediatric Sickle Cell Program
🇺🇸Charlotte, North Carolina, United States
Cohen Children's Medical Center of NY (CCMC)
🇺🇸New Hyde Park, New York, United States
Center for Children's Cancer & Blood Disorders
🇺🇸Syracuse, New York, United States
Ohio Region VI Sickle Cell Program
🇺🇸Akron, Ohio, United States
The Children's Medical Center of Dayton
🇺🇸Dayton, Ohio, United States
Medical University of SC-Pediatric Sickle Cell Center
🇺🇸Charleston, South Carolina, United States
M. Francisco Gonzalez, M.D., P.A.
🇺🇸Columbia, South Carolina, United States
Diggs-Kraus Sickle Cell Center
🇺🇸Memphis, Tennessee, United States
Peninsula Cancer Institute
🇺🇸Newport News, Virginia, United States
Baylor College of Medicine-Texas Children's Hospital
🇺🇸Houston, Texas, United States
Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
🇺🇸San Diego, California, United States
Innovative Medical Research
🇺🇸Miami, Florida, United States
Miami Children's Hospital
🇺🇸Miami, Florida, United States
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
Meharry Comprehensive Sickle Cell Center
🇺🇸Nashville, Tennessee, United States
Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
Central Tampa Hematology and Oncology Associates
🇺🇸Tampa, Florida, United States
St. Joseph Children's Hospital
🇺🇸Tampa, Florida, United States
Maimonides Medical Center
🇺🇸Brooklyn, New York, United States
M.D. Anderson Cancer Center Orlando
🇺🇸Orlando, Florida, United States