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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) (Gen/Phen)

This study has been terminated.
(Funds for study ended September 30, 2008.)
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI) Identifier:
First received: September 10, 2007
Last updated: July 11, 2016
Last verified: November 2008
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.

Anemia, Sickle Cell

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Sickle Cell Centers (CSCC) Collaborative Genotype-Phenotype Database and Sample Repository

Resource links provided by NLM:

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Biospecimen Retention:   Samples With DNA
Plasma, Lymphocytes, Whole blood, RBC hemolysate, DNA

Enrollment: 3640
Study Start Date: August 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Detailed 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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult and pediatric patients who are enrolled in the C-Data project are eligible for this study. (C-Data eligibility: 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 1 of the CSCC are eligible for inclusion in the C-Data project.)

Inclusion Criteria:

  • Participating in the C-Data project

Exclusion Criteria:

  • Unable to undergo blood collection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00528203

United States, California
Children's Hospital Oakland
Oakland, California, United States, 94609
University of California, San Francisco
San Francisco, California, United States, 94134
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Children's Hospital of Boston
Boston, Massachusetts, United States, 02115
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10463
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Children's Medical Hospital of Dallas
Dallas, Texas, United States, 75235
University of Texas Southwestern & Parkland
Dallas, Texas, United States, 75235
University of Texas at Galveston
Galveston, Texas, United States, 77555
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Carolyn Hoppe, MD Children's Hospital & Research Center Oakland
  More Information

Responsible Party: Carolyn Hoppe, MD, Children's Hospital Oakland Identifier: NCT00528203     History of Changes
Other Study ID Numbers: 517
U54HL070587 ( US NIH Grant/Contract Award Number )
Study First Received: September 10, 2007
Last Updated: July 11, 2016

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Sickle Cell Disease
Sickle Cell Anemia

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn processed this record on May 25, 2017