A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients
FISCO
1 other identifier
observational
498
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 11, 2010
CompletedFirst Posted
Study publicly available on registry
October 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedDecember 9, 2019
May 1, 2015
4.7 years
October 11, 2010
December 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
up to 5 years
Secondary Outcomes (2)
Data collection
up to 5 years
Measure Sickle cell crisis and hospitalizations
up to 5 years
Study Arms (3)
No treatment
Patients aged 2 to less than 12
No treatment patients aged 12 to less than 18
Patients aged 12 to less than 18
No treatment Patients greater than 18 years
patients greater than 18 years
Eligibility Criteria
Patients with Sickle cell disease age 2 years and older
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (42)
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205, United States
Children's Hospital Oakland (CHO)
Oakland, California, 94609, United States
Children's Hospital of Orange County Sickle Cell Disease Center
Orange, California, 92668, United States
Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
San Diego, California, 92123, United States
Hematology Oncology, P.C.
Stamford, Connecticut, 06902, United States
Howard University
Washington D.C., District of Columbia, 20060, United States
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, 33308, United States
Miami Children's Hospital
Miami, Florida, 33155, United States
Innovative Medical Research
Miami, Florida, 33179, United States
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806, United States
All Children's Hospital
St. Petersburg, Florida, 33701, United States
Central Tampa Hematology and Oncology Associates
Tampa, Florida, 33607, United States
St. Joseph Children's Hospital
Tampa, Florida, 33607, United States
University of Illinois at Chicago, Dept of Pediatrics
Chicago, Illinois, 60612, United States
Abington Hematology Oncology Associates, Inc
Oak Lawn, Illinois, 60453, United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112, United States
LSU Department of Pediatrics Children's Hospital
New Orleans, Louisiana, 70118, United States
Johns Hopkins University Division of Hematology
Baltimore, Maryland, 21205, United States
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735, United States
Children's Hospital Boston - Harvard
Boston, Massachusetts, 02115, United States
Boston Comprehensive Sickle Cell Center
Boston, Massachusetts, 02118, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
University of Missouri Child Health, Division of Pediatric Hematology/Oncology
Columbia, Missouri, 65212, United States
Children's Mercy Hospital
Kansas City, Missouri, 64108, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Newark Beth Israel Medical Center
Newark, New Jersey, 07112, United States
Maimonides Medical Center
Brooklyn, New York, 11209, United States
New York Methodist Hospital Dept of Med/Sickle Cell Program
Brooklyn, New York, 11215, United States
Interfaith Medical Center-Comprehensive Sickle Cell Program
Brooklyn, New York, 11238, United States
Cohen Children's Medical Center of NY (CCMC)
New Hyde Park, New York, 11040, United States
Center for Children's Cancer & Blood Disorders
Syracuse, New York, 13210, United States
Presbyterian Hospital Pediatric Sickle Cell Program
Charlotte, North Carolina, 28204, United States
Ohio Region VI Sickle Cell Program
Akron, Ohio, 44308, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229-3039, United States
The Children's Medical Center of Dayton
Dayton, Ohio, 45404, United States
Medical University of SC-Pediatric Sickle Cell Center
Charleston, South Carolina, 29425, United States
M. Francisco Gonzalez, M.D., P.A.
Columbia, South Carolina, 29203, United States
Diggs-Kraus Sickle Cell Center
Memphis, Tennessee, 38103, United States
Meharry Comprehensive Sickle Cell Center
Nashville, Tennessee, 37208, United States
Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-6310, United States
Baylor College of Medicine-Texas Children's Hospital
Houston, Texas, 77030-2399, United States
Peninsula Cancer Institute
Newport News, Virginia, 23601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2010
First Posted
October 13, 2010
Study Start
January 1, 2010
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
December 9, 2019
Record last verified: 2015-05