Protocol Number: 08-DK-0004

Title:

High Throughput Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease

Number:

08-DK-0004

Summary:

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.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

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.

Special Instructions:

Currently Not Provided

Keywords:

Sickle Hemoglobin

Erythrocytes

Drug Screen

Sickle Cell Trait

Sickle Cell Disease

Recruitment Keyword(s):

Sickle Cell Trait

Sickle Cell Disease

Condition(s):

Sickle Cell Trait

Sickle Cell Disease

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Pauling, L., Itano, H. A., Singer, S. J. & Wells, I. C. Sickle cell anemia, a molecular disease. Science. 1949 Nov 25;110(2865):543-8.

Ingram, V. M. Gene mutations in human haemoglobin: the chemical difference between normal and sickle cell haemoglobin. Nature. 1957 Aug 17;180(4581):326-8.

Charache S, Terrin ML, Moore RD, Dover GJ, Barton FB, Eckert SV, McMahon RP, Bonds DR. Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. Investigators of the Multicenter Study of Hydroxyurea in Sickle Cell Anemia. N Engl J Med. 1995 May 18;332(20):1317-22

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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