Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data])

NCT ID: NCT00529061

Last Updated: 2016-07-12

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

TERMINATED

Total Enrollment

3640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-09-30

Brief Summary

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Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. The purpose of this study is to gather medical information from children and adults with SCD and establish a database so that researchers can contact people to participate in future SCD research studies.

Detailed Description

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SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." The Comprehensive Sickle Cell Centers (CSCC) is a network of 10 centers that conduct research to improve health care and treatment options for people with SCD. This study, the Collaborative Data Project (C-Data), will establish a comprehensive database of children and adults receiving medical care at participating CSCC research centers who are potentially eligible for inclusion in SCD clinical trials. The main purposes of this study are the following: 1) to gather medical information about a large number of people with SCD over a long period of time; 2) to identify potential participants for future SCD clinical trials; 3) to collect information about how SCD affects quality of life; and 4) to evaluate the relationship between SCD patients' characteristics and medical events.

In this study, research staff will review participants' medical records twice a year for at least 5 years. Information will be collected regarding participants' medical history, physical exams, blood tests, and demographics. Once a year, participants will take part in a short interview about their health and lifestyle. Participants will also complete quality-of-life and patient satisfaction questionnaires during the first year of the study and may complete additional questionnaires in the future. During an interview, participants will be asked general questions about their experience with SCD and more specific questions on headaches and any possible relation they may have to SCD pain. Participants may also be asked to provide a blood sample at some point during the study. CSCC researchers will analyze the information in the database and may contact participants in the future to see if they are interested in enrolling in SCD clinical trials.

Conditions

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Anemia, Sickle Cell

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of SCD
* Evaluated within the 24 months prior to study entry in the hospital or clinical setting
* Expected to return episodically or regularly for care at one of the CSCCs

Exclusion Criteria

* Deceased CSCC patient
* Inactive CSCC patient
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Responsible Party

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Rho, Inc. - CSCC Statistics and Data Management Center

Principal Investigators

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Susi Lieff, PhD

Role: PRINCIPAL_INVESTIGATOR

Statistics and Data Management Center (SDMC) (RhoFed)

Locations

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Children's Hospital of Oakland

Oakland, California, United States

Site Status

University of California, San Francisco

San Francisco, California, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Children's Hospital of Boston

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status

University of Oklahoma Health Sciences

Oklahoma City, Oklahoma, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status

Saint Jude Children's Hospital

Memphis, Tennessee, United States

Site Status

Children's Medical Center of Dallas

Dallas, Texas, United States

Site Status

University of Texas Southwestern and Parkland

Dallas, Texas, United States

Site Status

University of Texas at Galveston

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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U54HL070587-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1401

Identifier Type: -

Identifier Source: org_study_id

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