Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03937817|
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : January 27, 2023
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.
To collect samples to use for research on blood disorders.
People ages 18-70 who have blood disorders. Healthy volunteers without blood disorders are also needed.
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.
|Condition or disease|
|Alpha and Beta Thalassemia Sickle Cell Disease Malaria Human Physiology|
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 Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants|
|Actual Study Start Date :||September 25, 2019|
|Estimated Primary Completion Date :||March 31, 2029|
|Estimated Study Completion Date :||March 31, 2029|
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.
- Collect biological specimens (saliva, urine, blood, adipose tissue, bronchial brushing, and/or BAL) [ Time Frame: Throughout study ]Development and optimization of scientific assays and research of globin variants, sickle cell disease, malaria, or other related diseases.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937817
|Contact: Mary J Jackson, R.N.||(301) firstname.lastname@example.org|
|Contact: Amy P Ruhl, M.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY dial 711 firstname.lastname@example.org|
|Principal Investigator:||Amy P Ruhl, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|