Sickle Cell DiseaseFISCONCT01220115
A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients
An observational study of Sickle Cell Disease, run by Novartis at 42 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Sickle Cell Disease
- How many people
- 498 participants
- Where
- 42 sitesUnited States
- Study dates
- Jan 2010to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Sickle cell disease age 2 years and older
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Ohio Region VI Sickle Cell Program
Akron, Ohio, 44308
Johns Hopkins University Division of Hematology
Baltimore, Maryland, 21205
Children's Hospital Boston - Harvard
Boston, Massachusetts, 02115
Boston Comprehensive Sickle Cell Center
Boston, Massachusetts, 02118
Maimonides Medical Center
Brooklyn, New York, 11209
New York Methodist Hospital Dept of Med/Sickle Cell Program
Brooklyn, New York, 11215
Interfaith Medical Center-Comprehensive Sickle Cell Program
Brooklyn, New York, 11238
Medical University of SC-Pediatric Sickle Cell Center
Charleston, South Carolina, 29425
Presbyterian Hospital Pediatric Sickle Cell Program
Charlotte, North Carolina, 28204
University of Illinois at Chicago, Dept of Pediatrics
Chicago, Illinois, 60612
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45229-3039
Oncology-Hematology Associates, P.A.
Clinton, Maryland, 20735
University of Missouri Child Health, Division of Pediatric Hematology/Oncology
Columbia, Missouri, 65212
M. Francisco Gonzalez, M.D., P.A.
Columbia, South Carolina, 29203
The Children's Medical Center of Dayton
Dayton, Ohio, 45404
Broward Oncology Associates, P.A.
Fort Lauderdale, Florida, 33308
Baylor College of Medicine-Texas Children's Hospital
Houston, Texas, 77030-2399
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Children's Mercy Hospital
Kansas City, Missouri, 64108
Research Medical Center
Kansas City, Missouri, 64132
Hematology Oncology Services of Arkansas
Little Rock, Arkansas, 72205
Diggs-Kraus Sickle Cell Center
Memphis, Tennessee, 38103
Miami Children's Hospital
Miami, Florida, 33155
Innovative Medical Research
Miami, Florida, 33179
Meharry Comprehensive Sickle Cell Center
Nashville, Tennessee, 37208
Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232-6310
Cohen Children's Medical Center of NY (CCMC)
New Hyde Park, New York, 11040
Tulane University School of Medicine
New Orleans, Louisiana, 70112
LSU Department of Pediatrics Children's Hospital
New Orleans, Louisiana, 70118
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Peninsula Cancer Institute
Newport News, Virginia, 23601
Abington Hematology Oncology Associates, Inc
Oak Lawn, Illinois, 60453
Children's Hospital Oakland (CHO)
Oakland, California, 94609
Children's Hospital of Orange County Sickle Cell Disease Center
Orange, California, 92668
M.D. Anderson Cancer Center Orlando
Orlando, Florida, 32806
Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center
San Diego, California, 92123
All Children's Hospital
St. Petersburg, Florida, 33701
Hematology Oncology, P.C.
Stamford, Connecticut, 06902
Center for Children's Cancer & Blood Disorders
Syracuse, New York, 13210
Central Tampa Hematology and Oncology Associates
Tampa, Florida, 33607
St. Joseph Children's Hospital
Tampa, Florida, 33607
Howard University
Washington D.C., District of Columbia, 20060
About this study
Official title: 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.
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, iron over load
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
Measured: up to 5 years
Secondary outcomes (2)
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
Measured: up to 5 years
Measure Sickle cell crisis and hospitalizations
To evaluate whether patients on regular transfusion protocol have fewer crisis and hospitalizations
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220115
- Sponsor's protocol ID
- CICL670AUS38
- Acronym
- FISCO
- Status last verified
- May 2015
- First submitted
- 11 Oct 2010
- Last updated
- 9 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients
- ClinicalTrials.gov ID
- NCT01220115
- Acronym / sponsor ID
- FISCO / CICL670AUS38
- Conditions
- Sickle Cell Disease
- Keywords
- sickle cell disease, iron over load
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Sickle cell disease age 2 years and older
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease
Time frame: up to 5 years
2 secondary outcomes
Data collection
Time frame: up to 5 years
Measure Sickle cell crisis and hospitalizations
Time frame: up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2019.
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A Dose-Finding Study of Tebapivat to Assess Efficacy, and Safety in Participants With Sickle Cell Disease (SCD)
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by Novartis at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Document current treatment patterns, natural history and outcomes in patients with sickle cell disease (time frame: up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.