Understanding the natural history of sickle cell disease
Studies of the Natural History of Sickle Cell Disease
This study is trying to learn more about sickle cell disease and its painful episodes by collecting health information and samples from people living with the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3500 (estimated) |
| Ages | 2 Years to 90 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 3 sites (Washington D.C., District of Columbia and 2 other locations) |
| Trial ID | NCT00081523 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather comprehensive data on individuals with sickle cell disease to better understand the disease's mechanisms and complications, particularly vaso-occlusive painful crises. Participants will receive routine medical care while contributing to a repository of biospecimens and clinical data. The study will involve medical evaluations, laboratory tests, and may include follow-up visits as needed. The goal is to enhance knowledge of the disease's natural history and inform future treatment options.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 2 years and older with known or suspected sickle cell disease who can provide informed consent.
Not a fit: Patients who are less than 2 years old or unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of sickle cell disease, potentially enhancing patient care and treatment outcomes.
How similar studies have performed: Other studies focusing on the natural history and mechanisms of sickle cell disease have shown promise, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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. Individuals with known or suspected sickle cell disease will meet the inclusion criteria to enroll in this protocol and can undergo study activities. However, if the individual is found not to have sickle cell disease after enrollment, they will be removed from the protocol, and their research samples will be discarded but they will be counted toward the study accrual. The study team will notify the individual about their removal from the study and explain the reason for it. Any necessary regulatory reporting will also be completed.
Where this trial is running
Washington D.C., District of Columbia and 2 other locations
- Childrens National Health Center — Washington D.C., District of Columbia, United States (Recruiting)
- Suburban Hospital — Bethesda, Maryland, United States (Completed)
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Swee Lay Thein, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Nancy A Asomaning
- Email: nancy.asomaning@nih.gov
- Phone: (301) 605-0398
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.