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 : June 2, 2023
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|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 :||3500 participants|
|Official Title:||Studies of the Natural History of Sickle Cell Disease|
|Actual Study Start Date :||April 29, 2004|
Individuals with known or suspected sickle cell disease
- To gather, through clinical experience, information regarding the natural history, co-morbid conditions and outcomes, and complications relating to sickle cell disease and other hemolytic disorders in minority/ethnic patients [ Time Frame: ongoing ]Better characterization of the natural history of sickle cell disease
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, Learn About Clinical Studies.
|Ages Eligible for Study:||2 Years to 90 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
- Individuals with known or suspected sickle cell disease
- 2 years of age and older
- Willing to provide informed consent or appropriate informed consent from parent or legal guardian
- Patients seen at sickle outpatient clinics at any one of the participating centers (CNHS or NIH).
- Patient and/or guardian unable and unwilling to give informed consent or assent.
- Patients less than 2 years of age.
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: Mai Hill, R.N.||(301) email@example.com|
|United States, District of Columbia|
|Childrens National Health Center||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Deepika Darbari, M.D. 202-476-6393 firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||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 TTY dial 711 email@example.com|
|Principal Investigator:||Swee Lay Thein, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||National Heart, Lung, and Blood Institute (NHLBI)|
|Other Study ID Numbers:||
|First Posted:||April 15, 2004 Key Record Dates|
|Last Update Posted:||June 2, 2023|
|Last Verified:||April 24, 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||.The team is in the process of making a determination.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Acute Chest Syndrome
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn