MedPath

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

Terminated
Conditions
Anemia, Sickle Cell
Registration Number
NCT00529061
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
3640
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (19)

Children's Hospital of Oakland

🇺🇸

Oakland, California, United States

Kosair Children's Hospital

🇺🇸

Louisville, Kentucky, United States

Brigham & Women's Hospital

🇺🇸

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

🇺🇸

Philadelphia, Pennsylvania, United States

University of North Carolina-Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

Children's Hospital of Boston

🇺🇸

Boston, Massachusetts, United States

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Duke University

🇺🇸

Durham, North Carolina, United States

Cincinnati Children's Hospital

🇺🇸

Cincinnati, Ohio, United States

University of Oklahoma Health Sciences

🇺🇸

Oklahoma City, Oklahoma, United States

Thomas Jefferson University Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

St. Christopher's Hospital for Children

🇺🇸

Philadelphia, Pennsylvania, United States

Saint Jude Children's Hospital

🇺🇸

Memphis, Tennessee, United States

Children's Medical Center of Dallas

🇺🇸

Dallas, Texas, United States

University of Texas Southwestern and Parkland

🇺🇸

Dallas, Texas, United States

University of California, San Francisco

🇺🇸

San Francisco, California, United States

University of Miami

🇺🇸

Miami, Florida, United States

University of Texas at Galveston

🇺🇸

Galveston, Texas, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

© Copyright 2025. All Rights Reserved by MedPath