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NCT00528203 Clinical Trial

Establishing a Repository of Blood and DNA Samples From People With Sickle Cell Disease (Comprehensive Sickle Cell Centers Collaborative Genotype-Phenotype Database and Sample Repository)

Anemia, Sickle Cell Clinical Trial

— Gen/Phen  

Official title:
Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00528203
Other study ID # 517
Secondary ID U54HL070587
Status Terminated
Phase N/A
First received September 10, 2007
Last updated July 11, 2016
Start date August 2007
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 collect, test, and archive blood and DNA samples from children and adults with SCD to study the role that genes play in SCD. Blood and DNA samples will be stored for use in future SCD studies.

Description:

SCD is an inherited blood disorder that is caused by an abnormal type of hemoglobin. 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. The Collaborative Data Project (C-Data) is a CSCC study that is establishing a comprehensive database of children and adults with SCD who are receiving medical care at participating CSCC research centers. This study will initiate the development of a centralized laboratory that will collect, test, and archive blood and DNA samples from participants in the C-Data project for use in future SCD studies. The collection of blood and DNA samples will provide researchers with an important resource to better define the genetic diversity of SCD. In the future, genotype-phenotype correlation studies, population studies, and various other genetic studies may be conducted.

This study will enroll participants taking part in the C-Data project. For this study, participants will undergo a blood collection. The blood sample will then be sent to a lab to characterize the red blood cells and hemoglobin. DNA will be analyzed to identify genes that influence the severity of SCD. Blood and DNA will be stored for future genetic research in SCD and closely related disorders.

Recruitment information / eligibility
Status Terminated
Enrollment 3640
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Participating in the C-Data project

Exclusion Criteria:

- Unable to undergo blood collection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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 Hospital of Dallas Dallas Texas
United States University of Texas Southwestern & Parkland Dallas Texas
United States University of Texas at Galveston Galveston Texas
United States Children's Hospital Oakland Oakland California
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States St. Christopher's Hospital for Children 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, 

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