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

NCT ID: NCT01220115

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

498 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease

Keywords

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sickle cell disease iron over load

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

Patients aged 2 to less than 12

No interventions assigned to this group

No treatment patients aged 12 to less than 18

Patients aged 12 to less than 18

No interventions assigned to this group

No treatment Patients greater than 18 years

patients greater than 18 years

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Hematology Oncology Services of Arkansas

Little Rock, Arkansas, United States

Site Status

Children's Hospital Oakland (CHO)

Oakland, California, United States

Site Status

Children's Hospital of Orange County Sickle Cell Disease Center

Orange, California, United States

Site Status

Rady Children's Hopsital / UC San Diego University Hospital Sickle Cell Disease Center

San Diego, California, United States

Site Status

Hematology Oncology, P.C.

Stamford, Connecticut, United States

Site Status

Howard University

Washington D.C., District of Columbia, United States

Site Status

Broward Oncology Associates, P.A.

Fort Lauderdale, Florida, United States

Site Status

Miami Children's Hospital

Miami, Florida, United States

Site Status

Innovative Medical Research

Miami, Florida, United States

Site Status

M.D. Anderson Cancer Center Orlando

Orlando, Florida, United States

Site Status

All Children's Hospital

St. Petersburg, Florida, United States

Site Status

Central Tampa Hematology and Oncology Associates

Tampa, Florida, United States

Site Status

St. Joseph Children's Hospital

Tampa, Florida, United States

Site Status

University of Illinois at Chicago, Dept of Pediatrics

Chicago, Illinois, United States

Site Status

Abington Hematology Oncology Associates, Inc

Oak Lawn, Illinois, United States

Site Status

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status

LSU Department of Pediatrics Children's Hospital

New Orleans, Louisiana, United States

Site Status

Johns Hopkins University Division of Hematology

Baltimore, Maryland, United States

Site Status

Oncology-Hematology Associates, P.A.

Clinton, Maryland, United States

Site Status

Children's Hospital Boston - Harvard

Boston, Massachusetts, United States

Site Status

Boston Comprehensive Sickle Cell Center

Boston, Massachusetts, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

University of Missouri Child Health, Division of Pediatric Hematology/Oncology

Columbia, Missouri, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

Research Medical Center

Kansas City, Missouri, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

Maimonides Medical Center

Brooklyn, New York, United States

Site Status

New York Methodist Hospital Dept of Med/Sickle Cell Program

Brooklyn, New York, United States

Site Status

Interfaith Medical Center-Comprehensive Sickle Cell Program

Brooklyn, New York, United States

Site Status

Cohen Children's Medical Center of NY (CCMC)

New Hyde Park, New York, United States

Site Status

Center for Children's Cancer & Blood Disorders

Syracuse, New York, United States

Site Status

Presbyterian Hospital Pediatric Sickle Cell Program

Charlotte, North Carolina, United States

Site Status

Ohio Region VI Sickle Cell Program

Akron, Ohio, United States

Site Status

Cincinnati Children's Medical Center

Cincinnati, Ohio, United States

Site Status

The Children's Medical Center of Dayton

Dayton, Ohio, United States

Site Status

Medical University of SC-Pediatric Sickle Cell Center

Charleston, South Carolina, United States

Site Status

M. Francisco Gonzalez, M.D., P.A.

Columbia, South Carolina, United States

Site Status

Diggs-Kraus Sickle Cell Center

Memphis, Tennessee, United States

Site Status

Meharry Comprehensive Sickle Cell Center

Nashville, Tennessee, United States

Site Status

Sickle Cell Disease and Hemoglobinopathy Clinic Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Site Status

Baylor College of Medicine-Texas Children's Hospital

Houston, Texas, United States

Site Status

Peninsula Cancer Institute

Newport News, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CICL670AUS38

Identifier Type: -

Identifier Source: org_study_id