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)
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Purpose
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.
| Condition |
|---|
|
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 |
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) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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| 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 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| Children's Hospital of Boston | |
| Boston, Massachusetts, United States, 02115 | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| 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 | |
| Principal Investigator: | Carolyn Hoppe, MD | Children's Hospital & Research Center Oakland |
More Information
No publications provided
| Responsible Party: | Carolyn Hoppe, MD, Children's Hospital Oakland |
| ClinicalTrials.gov Identifier: | NCT00528203 History of Changes |
| Other Study ID Numbers: | 517, HL070587-08 |
| Study First Received: | September 10, 2007 |
| Last Updated: | November 6, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
|
Sickle Cell Disease Sickle Cell Anemia DNA |
Additional relevant MeSH terms:
|
Anemia Anemia, Sickle Cell Hematologic Diseases Anemia, Hemolytic, Congenital |
Anemia, Hemolytic Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 22, 2013