Natural History of Sickle Cell Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00081523|
Recruitment Status : Recruiting
First Posted : April 15, 2004
Last Update Posted : September 18, 2019
|Condition or disease|
This protocol will permit the establishment of a repository of biospecimens from individuals affected with sickle cell disease to identify and evaluate underlying disease mechanism(s), and to facilitate understanding of the pathogenesis and natural history of vaso-occlusive painful crisis and other complications of the disease. Patients will be evaluated with a medical history and physical examination and routine laboratory studies will be obtained as needed to assess diagnosis, disease activity, and disease complications and to monitor for treatment-related responses and toxicities. This protocol may also provide for the continued storage and analysis of clinical and research data, and biospecimens previously obtained from other NIH Institutional Review Board (IRB)-approved protocols with subject consent.
Patients eligible for other research protocols will be offered an opportunity to participate in these studies after signed informed consent has been obtained. Apart from such protocols, any medical care or additional tests/investigations recommended or provided to the patient will be consistent with routine standards of practice and will be provided in consultation with the patient's referring physician.
|Study Type :||Observational|
|Estimated Enrollment :||19998 participants|
|Official Title:||Studies of the Natural History of Sickle Cell Disease|
|Actual Study Start Date :||April 29, 2004|
patients who meet eligibility criteria.
- gather through clinical experience information regarding the natural history, co-morbid conditions and outcomes, and complicationsrelating to sickle cell disease and other hemolytic disorders in minority/ethnic patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00081523
|Contact: James Nichols, R.N.||(301) email@example.com|
|United States, District of Columbia|
|Childrens National Medical Center||Recruiting|
|Washington, District of Columbia, United States|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Contact: Darlene Allen (301) 435-1495 email@example.com|
|Principal Investigator:||Swee Lay Thein, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|