Blood Sampling for Research Related to Sickle Cell Disease
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|ClinicalTrials.gov Identifier: NCT00542230|
Recruitment Status : Recruiting
First Posted : October 11, 2007
Last Update Posted : April 27, 2023
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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 18 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 or disease|
|Sickle Cell Trait Sickle Cell Disease Sickle Cell Anemia|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||High Sensitivity Screening of Compound Libraries to Discover a Drug for the Treatment of Sickle Cell Disease|
|Actual Study Start Date :||November 7, 2007|
Sickle Cell Trait
Patient with sickle cell trait or disease
- To screen large compound libraries for anti-sickling activity, particularly compounds that are already FDA-approved drugs, with the goal of discovering a drug for treating sickle cell disease. [ Time Frame: daily ]To identify by high sensitivity in vitro screening methods additional compounds that inhibit sickling
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- INCLUSION CRITERIA:
- Patients with sickle cell trait
- Patients with known hemoglobinopathies involving one or two genes for sickle hemoglobin
- Healthy volunteers for control experiments
- Age range: adults greater than or equal to 18 years of age
- 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. HIV, Hepatitis B or Hepatitits C testing will not be done under this study. Participants must be co-enrolled under another NIH protocol where the screening evaluation has been performed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542230
|Contact: William A Eaton, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||William A Eaton, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Responsible Party:||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Other Study ID Numbers:||
|First Posted:||October 11, 2007 Key Record Dates|
|Last Update Posted:||April 27, 2023|
|Last Verified:||February 7, 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Sickle Cell Trait
Sickle Cell Disease
Anemia, Sickle Cell
Sickle Cell Trait
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn