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

Anemia, Sickle Cell Clinical Trial

— C-Data  

Official title:

Comprehensive Sickle Cell Centers Collaborative Data Project (C-Data)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00529061
• Other study ID #: 1401
• Secondary ID: U54HL070587-05
• Status: Terminated
• Phase: N/A
• First received: September 12, 2007
• Last updated: July 11, 2016
• Start date: March 2005
• Est. completion date: September 2008

Study information

• Verified date: November 2008
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 3640
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Anemia, Sickle Cell

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Children's Hospital of Boston	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Children's Medical Center of Dallas	Dallas	Texas
United States	University of Texas Southwestern and Parkland	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	University of Texas at Galveston	Galveston	Texas
United States	Kosair Children's Hospital	Louisville	Kentucky
United States	Saint Jude Children's Hospital	Memphis	Tennessee
United States	University of Miami	Miami	Florida
United States	Children's Hospital of Oakland	Oakland	California
United States	University of Oklahoma Health Sciences	Oklahoma City	Oklahoma
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States,