Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

⁃ 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.

⁃ PARTICIPANT EXCLUSION CRITERIA:

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Mary J Jackson, R.N.
alpha.study@nih.gov
(301) 761-5667
Backup
Hans C Ackerman, M.D.
hans.ackerman@nih.gov
(301) 761-5646
Time Frame
Start Date: 2019-09-25
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 300
Treatments
1
Healthy 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.
Authors
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov