A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients

Sickle Cell Disease Clinical Trial

— FISCO  

Official title:

A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220115
• Other study ID #: CICL670AUS38
• Status: Completed
• Start date: January 2010
• Est. completion date: September 2014

Study information

• Verified date: May 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 498
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Ohio Region VI Sickle Cell Program	Akron	Ohio
United States	Johns Hopkins University Division of Hematology	Baltimore	Maryland
United States	Boston Comprehensive Sickle Cell Center	Boston	Massachusetts
United States	Children's Hospital Boston - Harvard	Boston	Massachusetts
United States	Interfaith Medical Center-Comprehensive Sickle Cell Program	Brooklyn	New York
United States	Maimonides Medical Center	Brooklyn	New York
United States	New York Methodist Hospital Dept of Med/Sickle Cell Program	Brooklyn	New York
United States	Medical University of SC-Pediatric Sickle Cell Center	Charleston	South Carolina
United States	Presbyterian Hospital Pediatric Sickle Cell Program	Charlotte	North Carolina
United States	University of Illinois at Chicago, Dept of Pediatrics	Chicago	Illinois
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Oncology-Hematology Associates, P.A.	Clinton	Maryland
United States	M. Francisco Gonzalez, M.D., P.A.	Columbia	South Carolina
United States	University of Missouri Child Health, Division of Pediatric Hematology/Oncology	Columbia	Missouri
United States	The Children's Medical Center of Dayton	Dayton	Ohio
United States	Broward Oncology Associates, P.A.	Fort Lauderdale	Florida
United States	Baylor College of Medicine-Texas Children's Hospital	Houston	Texas
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	Research Medical Center	Kansas City	Missouri
United States	Hematology Oncology Services of Arkansas	Little Rock	Arkansas
United States	Diggs-Kraus Sickle Cell Center	Memphis	Tennessee
United States	Innovative Medical Research	Miami	Florida
United States	Miami Children's Hospital	Miami	Florida
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	Cohen Children's Medical Center of NY (CCMC)	New Hyde Park	New York
United States	LSU Department of Pediatrics Children's Hospital	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Peninsula Cancer Institute	Newport News	Virginia
United States	Abington Hematology Oncology Associates, Inc	Oak Lawn	Illinois
United States	Children's Hospital Oakland (CHO)	Oakland	California
United States	Children's Hospital of Orange County Sickle Cell Disease Center	Orange	California
United States	M.D. Anderson Cancer Center Orlando	Orlando	Florida
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center	San Diego	California
United States	Hematology Oncology, P.C.	Stamford	Connecticut
United States	Center for Children's Cancer & Blood Disorders	Syracuse	New York
United States	Central Tampa Hematology and Oncology Associates	Tampa	Florida
United States	St. Joseph Children's Hospital	Tampa	Florida
United States	Howard University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Document current treatment patterns, natural history and outcomes in patients with sickle cell disease		up to 5 years
Secondary	Data collection	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	up to 5 years
Secondary	Measure Sickle cell crisis and hospitalizations	To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations	up to 5 years