Blood Sampling for Research Related to Sickle Cell Disease
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Purpose
This study will collect representative blood samples from healthy children and adults and from children and adults who have unique red blood cell features that are related to sickle cell disease. Sickle cell disease is a blood disease that limits the ability of red blood cells to carry oxygen throughout the body. The purpose of the study is to collect a variety of blood samples that may then be used to investigate advances and potential new drug treatments for sickle cell disease.
Volunteers must be at least 8 years of old. Samples will be taken both from healthy volunteers and from volunteers who have unique red blood cell features that are related to sickle cell disease. Candidates will be screened with a medical history.
During the study, participants will undergo a one- to two-hour outpatient procedure at the National Institutes of Health Clinical Center. Once researchers have explained the study and obtained the participant's consent, participants will donate 8 cc (approximately 2 teaspoons) of blood.
Because repeat testing helps researchers validate study findings, participants who have the unique red blood cell features mentioned above may also be asked if they are willing to return and donate another 2 cc to 8 cc of blood for additional studies. The amount of blood drawn will not exceed 50 ml with any eight-week period for adults or 7 cc within any six-week period for children.
| Condition |
|---|
|
Sickle Cell Trait Sickle Cell Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | High Throughput Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease |
| Estimated Enrollment: | 99999999 |
| Study Start Date: | October 2007 |
The critical event leading to serious morbidity in sickle cell disease is the distortion (sickling) of red blood cells caused by abnormal hemoglobin. Currently, only hydroxyurea is proven to reduce sickling tendency and it is not fully effective. This protocol seeks to identify by high throughput in vitro screening methods additional compounds that inhibit sickling of red blood cells. Subjects with sickle cell trait or disease and normal volunteers will be asked to donate blood samples for studies to verify their hemoglobinopathies and then periodically donate small volume samples of fresh blood for use in ongoing high throughput screening tests to identify potentially clinically useful anti-sickling drugs.
Eligibility| Ages Eligible for Study: | 8 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
- INCLUSION CRITERIA:
- Patients with sickle cell trait
- Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin
- Healthy volunteers for control experiments
- Women who are pregnant or breastfeeding are eligible to enroll in this protocol.
- Age range: Minors greater than or equal to 8 years of age and adults greater than or equal to 18 years of age
EXCLUSION CRITERIA:
- Subjects who are unable to comprehend the investigational nature of the laboratory research are ineligible to enroll in this protocol.
- As a safety precaution in handling the blood samples, patients with HIV, Hepatitis B or Hepatitis C will be excluded from the study. Healthy volunteers will not be tested for HIV, Hepatitis B or Hepatitis C unless they are participants in another protocol(s) where the screening evaluation has been performed.
Contacts and Locations| Contact: William A Eaton, M.D. | (301) 496-6030 | eaton@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 prpl@mail.cc.nih.gov | |
| Principal Investigator: | William A Eaton, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00542230 History of Changes |
| Other Study ID Numbers: | 080004, 08-DK-0004 |
| Study First Received: | October 10, 2007 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Sickle Hemoglobin Erythrocytes Drug Screen Sickle Cell Trait Sickle Cell Disease |
Additional relevant MeSH terms:
|
Anemia, Sickle Cell Sickle Cell Trait Anemia, Hemolytic, Congenital Anemia, Hemolytic |
Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 19, 2013