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

Recruiting

• Conditions: Sickle Cell Disease; Alpha and Beta Thalassemia; Malaria; Human Physiology

• Registration Number: NCT03937817
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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: 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.

Detailed Description

The Physiology Unit of the Laboratory of Malaria and Vector Research studies the role of globin variants in erythroid and non-erythroid tissues. We hope to better understand the mechanism(s) through which alpha and beta globin variants impact malaria, sickle cell disease, or other diseases involving inflammation or endothelial dysfunction.

The collection of human specimens from healthy volunteers and patients with malaria, sickle cell disease, or other diseases involving inflammation or endothelial dysfunction is necessary for the development of laboratory and physiological assays to further basic and clinical research studies. This protocol defines the purposes for which specimens will be collected and establishes general conditions under which sample collection will be performed. Development of assays and our research into the roles of alpha and beta globin in normal human physiology, as well as in the pathogenesis of malaria and sickle cell disease, requires laboratory analysis of saliva/buccal swab, urine, blood, adipose tissue, bronchial brushing, and/or bronchoalveolar lavage specimens from human volunteers.

Study Timeline

• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-06
• Study Start: 2019-09-25
• Status Verified: 2024-10-10
• Last Update Submitted: 2024-12-21
• Last Update Posted: 2024-12-27
• Primary Completion: 2029-03-31
• Study Completion: 2029-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect biological specimens (saliva, urine, blood, adipose tissue, bronchial brushing, and/or BAL)	Throughout study	Development and optimization of scientific assays and research of globin variants, sickle cell disease, malaria, or other related diseases.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States