Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Part of paid clinical trials in Bethesda, Maryland.
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study ID
- NCT03937817
- Status
- Recruiting
Conditions
- Alpha and Beta Thalassemia
- Human Physiology
- Malaria
- Sickle Cell Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Accepted
Study Details
Background: Blood disorders like sickle cell disease and malaria affect many people around the world. Researchers want to learn more about blood disorders. To do this, they need to collect biological samples from people with blood disorders. They also need to collect samples from healthy people. Objective: To collect samples to use for research on blood disorders. Eligibility: People ages 18-70 who have blood disorders. Healthy volunteers without blood disorders are also needed. Design: Participants will be screened with a medical history, physical exam, and blood and urine tests. Participants will give one or more samples. They will give them over 5 years. They can choose not to give any of the samples: Saliva: Participants will spit into a tube. They may also have the inside of their mouth swabbed. Urine: Participants will urinate into a cup. Blood and blood waste products: Blood will be taken through a needle in the participant s arm. Fat samples: An area on the participant s belly or buttock will be numbed. A small cut will be made into the skin and a small piece of fat removed. Mucus and cells from the lungs: The participant will be sedated. A flexible tube will be inserted through the nose or mouth into the lung airways. These participants will also have a physical exam, chest x-ray, and heart tests after the procedure. ...
Key Dates
- Start date
- Sep 25, 2019
- Status verified
- Feb 2026
- Primary completion
- Mar 31, 2029
- Completion
- Mar 31, 2029
Study Design
- Enrollment
- 300 participants (estimated)
Arms
- Arm: 1Healthy volunteers and patients with hematologic and hemolytic diseases, including alpha and beta globin variants, sickle cell disease, malaria, or other diseases involving inflammation or endothelial dysfunction.
Primary Outcome Measure
Collect biological specimens (saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and/or BAL) [ Time Frame: Throughout study ]
Central Contacts
- Mary J Jackson, R.N.(301) 761-5667
- Hans C Ackerman, M.D.(301) 761-5646
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 |
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