Natural History of Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Blood Cancer, Anemia, Hematology |
| Therapuetic Areas: | Hematology, Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 2/28/2019 |
| Start Date: | April 29, 2004 |
| Contact: | James Nichols, R.N. |
| Email: | jim.nichols@nih.gov |
| Phone: | (301) 402-2105 |
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.
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.
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.
- 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.
We found this trial at
2
sites
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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