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

December 5, 2019 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Hematology Oncology Services of Arkansas
    • California
      • Oakland, California, United States, 94609
        • Children's Hospital Oakland (CHO)
      • Orange, California, United States, 92668
        • Children's Hospital of Orange County Sickle Cell Disease Center
      • San Diego, California, United States, 92123
        • Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
    • Connecticut
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology, P.C.
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Broward Oncology Associates, P.A.
      • Miami, Florida, United States, 33155
        • Miami Children's Hospital
      • Miami, Florida, United States, 33179
        • Innovative Medical Research
      • Orlando, Florida, United States, 32806
        • M.D. Anderson Cancer Center Orlando
      • Saint Petersburg, Florida, United States, 33701
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • Central Tampa Hematology and Oncology Associates
      • Tampa, Florida, United States, 33607
        • St. Joseph Children's Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago, Dept of Pediatrics
      • Oak Lawn, Illinois, United States, 60453
        • Abington Hematology Oncology Associates, Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • New Orleans, Louisiana, United States, 70118
        • LSU Department of Pediatrics Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University Division of Hematology
      • Clinton, Maryland, United States, 20735
        • Oncology-Hematology Associates, P.A.
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston - Harvard
      • Boston, Massachusetts, United States, 02118
        • Boston Comprehensive Sickle Cell Center
    • Michigan
      • Kalamazoo, Michigan, United States, 49007-3731
        • West Michigan Cancer Center
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Child Health, Division of Pediatric Hematology/Oncology
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
    • New York
      • Brooklyn, New York, United States, 11209
        • Maimonides Medical Center
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital Dept of Med/Sickle Cell Program
      • Brooklyn, New York, United States, 11238
        • Interfaith Medical Center-Comprehensive Sickle Cell Program
      • New Hyde Park, New York, United States, 11040
        • Cohen Children's Medical Center of NY (CCMC)
      • Syracuse, New York, United States, 13210
        • Center for Children's Cancer & Blood Disorders
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital Pediatric Sickle Cell Program
    • Ohio
      • Akron, Ohio, United States, 44308
        • Ohio Region VI Sickle Cell Program
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Medical Center
      • Dayton, Ohio, United States, 45404
        • The Children's Medical Center of Dayton
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of SC-Pediatric Sickle Cell Center
      • Columbia, South Carolina, United States, 29203
        • M. Francisco Gonzalez, M.D., P.A.
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Diggs-Kraus Sickle Cell Center
      • Nashville, Tennessee, United States, 37208
        • Meharry Comprehensive Sickle Cell Center
      • Nashville, Tennessee, United States, 37232-6310
        • Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
    • Texas
      • Houston, Texas, United States, 77030-2399
        • Baylor College of Medicine-Texas Children's Hospital
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Peninsula Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Sickle cell disease age 2 years and older

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection
Time Frame: 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
up to 5 years
Measure Sickle cell crisis and hospitalizations
Time Frame: up to 5 years
To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

October 11, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Actual)

December 9, 2019

Last Update Submitted That Met QC Criteria

December 5, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICL670AUS38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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