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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

2 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hematology Oncology Services of Arkansas, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Document current treatment patterns, natural history and outcomes in patients with sickle cell disease

Time frame: up to 5 years

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Acronym: FISCO

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Oct 13, 2010
Registry last updated: Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed