Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants (NCT03937817) | Clinical Trial Compass
RecruitingNot Applicable
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
United States300 participantsStarted 2019-09-25
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Aged 18-70 years.
✓. Able to provide informed consent.
✓. Willing to allow biological samples to be stored for future research.
✓. Willing to provide one or more of the following tissues: saliva, urine, blood, blood waste products, adipose tissue, bronchial brushing, and/or BAL samples.
✓. Willing to allow genetic testing on collected biological samples.
Exclusion criteria
✕. Pregnancy.
✕. Positive testing for hepatitis B virus, hepatitis C virus, or HIV (as determined by serum screening tests or relevant viral quantitative studies.)
✕. Any condition that requires active medical intervention or monitoring to avert serious danger to the individual s health or wellbeing.
✕. Any condition that, in the opinion of the PI, contraindicates participation in this study.