Natural History of Sickle Cell Disease

Pain Crisis Clinical Trial

Official title:

Studies of the Natural History of Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00081523
• Other study ID #: 040161
• Secondary ID: 04-H-0161
• Status: Recruiting
• Start date: April 29, 2004

Study information

• Verified date: June 17, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Mai Hill, R.N.
• Phone: (301) 402-2105
• Email: mai.hill[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3500
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 90 Years

Eligibility

• 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).

EXCLUSION CRITERIA:

• Patient and/or guardian unable and unwilling to give informed consent or assent.
• Patients less than 2 years of age.

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pain Crisis

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland
United States	Suburban Hospital	Bethesda	Maryland
United States	Childrens National Health Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Better characterization of the natural history of sickle cell disease	ongoing

External Links

•   NIH Clinical Center Detailed Web Page