NCT00542230 Blood Sampling for Research Related to Sickle Cell Disease
| NCT ID | NCT00542230 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Sickle Cell Trait |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2007-11-07 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2007-11-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
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 * Age range: 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. 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.
Contact & Investigator
William A Eaton, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT00542230 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Sickle Cell Trait. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00542230 currently recruiting?
Yes, NCT00542230 is actively recruiting participants. Contact the research team at eaton@mail.nih.gov for enrollment information.
Where is the NCT00542230 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00542230 clinical trial?
NCT00542230 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is William A Eaton, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 250 participants.
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