Clinical trial NCT00529061: Establishing a Database of People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Data Project [C-Data])
Official title: Comprehensive Sickle Cell Centers Collaborative Data Project (C-Data)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anemia, Sickle Cell
Keywords: Sickle Cell Disease
Sickle Cell Anemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2007-09-14
Enrollment: 3640
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult and pediatric patients who have been seen within the last 24 months in the hospital or clinical setting, and are expected to return episodically or regularly for care at one of the CSCCs, are eligible for inclusion in the C-Data project.

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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Children's Hospital of Oakland
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital of Boston
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina-Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences
state: Oklahoma
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: St. Christopher's Hospital for Children
state: Pennsylvania
city: Memphis
country: United States
facility: Saint Jude Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern and Parkland
state: Texas
city: Galveston
country: United States
facility: University of Texas at Galveston
state: Texas
Study officials:
affiliation: Statistics and Data Management Center (SDMC) (RhoFed)
name: Susi Lieff, PhD
role: PRINCIPAL_INVESTIGATOR
References: