Clinical trial NCT01220115: A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients
Official title: A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: sickle cell disease
iron over load
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-10-13
Enrollment: 498
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Sickle cell disease age 2 years and older

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
timeFrame: up to 5 years
Secondary outcomes:
measure: Data collection
timeFrame: up to 5 years
measure: Measure Sickle cell crisis and hospitalizations
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Hematology Oncology Services of Arkansas
state: Arkansas
city: Oakland
country: United States
facility: Children's Hospital Oakland (CHO)
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County Sickle Cell Disease Center
state: California
city: San Diego
country: United States
facility: Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
state: California
city: Stamford
country: United States
facility: Hematology Oncology, P.C.
state: Connecticut
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Broward Oncology Associates, P.A.
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Miami
country: United States
facility: Innovative Medical Research
state: Florida
city: Orlando
country: United States
facility: M.D. Anderson Cancer Center Orlando
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Central Tampa Hematology and Oncology Associates
state: Florida
city: Tampa
country: United States
facility: St. Joseph Children's Hospital
state: Florida
city: Chicago
country: United States
facility: University of Illinois at Chicago, Dept of Pediatrics
state: Illinois
city: Oak Lawn
country: United States
facility: Abington Hematology Oncology Associates, Inc
state: Illinois
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
city: New Orleans
country: United States
facility: LSU Department of Pediatrics Children's Hospital
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University Division of Hematology
state: Maryland
city: Clinton
country: United States
facility: Oncology-Hematology Associates, P.A.
state: Maryland
city: Boston
country: United States
facility: Children's Hospital Boston - Harvard
state: Massachusetts
city: Boston
country: United States
facility: Boston Comprehensive Sickle Cell Center
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Columbia
country: United States
facility: University of Missouri Child Health, Division of Pediatric Hematology/Oncology
state: Missouri
city: Kansas City
country: United States
facility: Children's Mercy Hospital
state: Missouri
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Newark
country: United States
facility: Newark Beth Israel Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital Dept of Med/Sickle Cell Program
state: New York
city: Brooklyn
country: United States
facility: Interfaith Medical Center-Comprehensive Sickle Cell Program
state: New York
city: New Hyde Park
country: United States
facility: Cohen Children's Medical Center of NY (CCMC)
state: New York
city: Syracuse
country: United States
facility: Center for Children's Cancer & Blood Disorders
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital Pediatric Sickle Cell Program
state: North Carolina
city: Akron
country: United States
facility: Ohio Region VI Sickle Cell Program
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Medical Center
state: Ohio
city: Dayton
country: United States
facility: The Children's Medical Center of Dayton
state: Ohio
city: Charleston
country: United States
facility: Medical University of SC-Pediatric Sickle Cell Center
state: South Carolina
city: Columbia
country: United States
facility: M. Francisco Gonzalez, M.D., P.A.
state: South Carolina
city: Memphis
country: United States
facility: Diggs-Kraus Sickle Cell Center
state: Tennessee
city: Nashville
country: United States
facility: Meharry Comprehensive Sickle Cell Center
state: Tennessee
city: Nashville
country: United States
facility: Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine-Texas Children's Hospital
state: Texas
city: Newport News
country: United States
facility: Peninsula Cancer Institute
state: Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: