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.
...
Condition or disease |
---|
Alpha Thalassemia Sickle Cell Disease Malaria Human Physiology |
Our goal is to understand the function of alpha globin in both erythroid and non-erythroid tissues. We hope to better understand the mechanism(s) through which alpha globin deletions protect against malaria, sickle cell disease or other diseases involving inflammation or endothelial dysfunction.
The Physiology Unit of the Laboratory of Malaria and Vector Research studies the role of alpha globin in erythroid and non-erythroid tissues. 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 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 |
Observational Model: | Other |
Time Perspective: | Prospective |
Official Title: | Collection of Human Biospecimens for Basic and Clinical Research Into Alpha Globin Variants |
Actual Study Start Date : | September 25, 2019 |
Estimated Primary Completion Date : | March 31, 2029 |
Estimated Study Completion Date : | March 31, 2029 |
Group/Cohort |
---|
1
Healthy volunteers and patients with hemolytic diseases, including sickle cell disease andmalaria, or other diseases involving inflammation or endothelial dysfunction.
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
PARTICIPANT INCLUSION CRITERIA:
Willing to allow genetic testing on collected biological samples.
PARTICIPANT EXCLUSION CRITERIA:
Any condition that, in the opinion of the principal investigator (PI), contraindicates participation in this study, will be cause for exclusion. However, there are no explicit exclusion criteria for the collection of saliva samples only.
-Exclusion Criteria for All Other Participants
The following exclusion criteria apply to all participants who will provide any of the following samples in-person at the NIH CC: urine, blood, adipose tissue, bronchial brushing, and/or BAL samples:
Any condition that, in the opinion of the PI, contraindicates participation in this study.
1. Hemoglobin < 10 g/dL for healthy female volunteers, < 12 g/dL for healthy male volunteers, or < 6 g/dL for participants with sickle cell disease or other chronic anemias.
-Additional Exclusion Criteria for Adipose Tissue Biopsy
Individuals meeting any of the following criteria will be excluded from undergoing adipose tissue biopsy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.
Use of aspirin (or acetylsalicylic acid) and nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted.
-Additional Exclusion Criteria for Bronchoscopy
Individuals meeting any of the following criteria will be excluded from undergoing bronchoscopy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.
Co-enrollment guidelines: Participants may be co-enrolled in other studies. However, the PI must be notified of co-enrollment.
Contact: Mary J Jackson, R.N. | (240) 292-4690 | jacksonmj@nih.gov |
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 TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Amy P Ruhl, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date | May 3, 2019 | ||||
First Posted Date | May 6, 2019 | ||||
Last Update Posted Date | May 7, 2021 | ||||
Actual Study Start Date | September 25, 2019 | ||||
Estimated Primary Completion Date | March 31, 2029 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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 alpha thalassemia, malaria, sickle cell disease, or other related diseases.
|
||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Collection of Human Biospecimens for Basic and Clinical Research Into Alpha Globin Variants | ||||
Official Title | Collection of Human Biospecimens for Basic and Clinical Research Into Alpha Globin Variants | ||||
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 |
Our goal is to understand the function of alpha globin in both erythroid and non-erythroid tissues. We hope to better understand the mechanism(s) through which alpha globin deletions protect against malaria, sickle cell disease or other diseases involving inflammation or endothelial dysfunction. The Physiology Unit of the Laboratory of Malaria and Vector Research studies the role of alpha globin in erythroid and non-erythroid tissues. 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 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 | ||||
Study Design | Observational Model: Other Time Perspective: Prospective |
||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Participants may be recruited from other NIH protocols, the NIH Clinical Research Healthy Volunteer Program, patient recruitment websites for the National Heart, Lung, and Blood Institute, community outreach, ResearchMatch, and clinicaltrials.gov. | ||||
Condition |
|
||||
Intervention | Not Provided | ||||
Study Groups/Cohorts | 1
Healthy volunteers and patients with hemolytic diseases, including sickle cell disease andmalaria, or other diseases involving inflammation or endothelial dysfunction.
|
||||
Publications * |
|
||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
300 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | March 31, 2029 | ||||
Estimated Primary Completion Date | March 31, 2029 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Any condition that, in the opinion of the principal investigator (PI), contraindicates participation in this study, will be cause for exclusion. However, there are no explicit exclusion criteria for the collection of saliva samples only. -Exclusion Criteria for All Other Participants The following exclusion criteria apply to all participants who will provide any of the following samples in-person at the NIH CC: urine, blood, adipose tissue, bronchial brushing, and/or BAL samples:
1. Hemoglobin < 10 g/dL for healthy female volunteers, < 12 g/dL for healthy male volunteers, or < 6 g/dL for participants with sickle cell disease or other chronic anemias. -Additional Exclusion Criteria for Adipose Tissue Biopsy Individuals meeting any of the following criteria will be excluded from undergoing adipose tissue biopsy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.
Use of aspirin (or acetylsalicylic acid) and nonsteroidal anti-inflammatory drugs (NSAIDs) are permitted. -Additional Exclusion Criteria for Bronchoscopy Individuals meeting any of the following criteria will be excluded from undergoing bronchoscopy. If the participant no longer meets any of these criteria at a later time, then they will be allowed to undergo this procedure.
Co-enrollment guidelines: Participants may be co-enrolled in other studies. However, the PI must be notified of co-enrollment. |
||||
Sex/Gender |
|
||||
Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
|
||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03937817 | ||||
Other Study ID Numbers | 190093 19-I-0093 |
||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement | Not Provided | ||||
Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) | ||||
Study Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Collaborators | Not Provided | ||||
Investigators |
|
||||
PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | May 4, 2021 |