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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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