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Natural History of Sickle Cell Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT00081523
First received: April 15, 2004
Last updated: November 16, 2016
Last verified: November 2016

April 15, 2004
November 16, 2016
April 2004
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Complete list of historical versions of study NCT00081523 on ClinicalTrials.gov Archive Site
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Natural History of Sickle Cell Disease
Studies of the Natural History of Sickle Cell Disease
This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated. Subjects will receive their general medical care outside the NIH and will be seen at our clinic or at CNHS with varying frequency. Subjects may be seen for multiple visits. Subjects may be asked to return for additional testing as needed. Clinical care for patients with sickle cell disease will be provided as appropriate through the Sickle Cell Clinic and the inpatient clinical center.

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.

Observational
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Sickle Cell Disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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  • INCLUSION CRITERIA:
  • Individuals with known or suspected sickle cell disease
  • 2 years of age and older
  • Willingness and capacity 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).

EXCLUSION CRITERIA:

  • Patient and/or guardian unable/unwilling to give informed consent or assent.
  • Patients less than 2 years of age.
Both
2 Years and older   (Child, Adult, Senior)
No
Contact: James Nichols, R.N. (301) 402-2105 jnichols@mail.nih.gov
United States
 
NCT00081523
040161, 04-H-0161
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National Heart, Lung, and Blood Institute (NHLBI)
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Swee Lay Thein, M.D. National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health Clinical Center (CC)
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP