A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease (SCD) Patients (FISCO)
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ClinicalTrials.gov Identifier: NCT01220115 |
Recruitment Status :
Completed
First Posted : October 13, 2010
Last Update Posted : December 9, 2019
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Condition or disease |
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Sickle Cell Disease |
Study Type : | Observational |
Actual Enrollment : | 498 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A 3-year, Prospective, Non-interventional, Multicenter Registry in Sickle Cell Disease Patients |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | September 2014 |
Actual Study Completion Date : | September 2014 |

Group/Cohort |
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No treatment
Patients aged 2 to less than 12
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No treatment patients aged 12 to less than 18
Patients aged 12 to less than 18
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No treatment Patients greater than 18 years
patients greater than 18 years
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- Document current treatment patterns, natural history and outcomes in patients with sickle cell disease [ Time Frame: up to 5 years ]
- 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
- 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

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220115

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis |
ClinicalTrials.gov Identifier: | NCT01220115 |
Other Study ID Numbers: |
CICL670AUS38 |
First Posted: | October 13, 2010 Key Record Dates |
Last Update Posted: | December 9, 2019 |
Last Verified: | May 2015 |
sickle cell disease iron over load |
Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |