Ignite Creation Date:
2024-05-06 @ 1:05 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03937817
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2019-05-03
Brief Title:
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Status:
RECRUITING
Status Verified Date:
2024-10-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mechanisms 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 salivabuccal swab urine blood adipose tissue bronchial brushing andor bronchoalveolar lavage specimens from human volunteers
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 salivabuccal swab urine blood adipose tissue bronchial brushing andor bronchoalveolar lavage specimens from human volunteers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 19-I-0093 | None | None | None |