Ignite Creation Date:
2024-07-17 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479837
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-27
Brief Title:
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Status:
RECRUITING
Status Verified Date:
2024-06-26
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
Staphylococcus aureus S aureus are bacteria that can make people sick Sometimes an S aureus infection can develop inside the spine these infections can lead to paralysis and death Researchers do not know how S aureus interacts with a person s cells to cause infections in the spine
Objective
To learn how S aureus interacts with cells in the body using tissues from tonsils discarded after standard surgery to remove them
Eligibility
People aged 2 years and older who are scheduled to have their tonsils removed
Design
Researchers will select participants for the study based on review of their existing medical records including results of blood tests any imaging scans including x-rays and reports about tissue specimens
Participants will answer questionnaires about their health and past infections They can do this online or on paper
Participants will collect a nasal swab 1 week before their surgery They will be given a tool that looks like a long cotton swab They will twirl it around inside their nose The swab will pick up cells and fluids that will be used for research
After their surgery the participant s surgeon will save samples of tonsil tissue The surgeon will send these tissue samples and the nasal swab to researchers at the NIH
These tissues and the swab will be used in studies to help researchers understand how S aureus interacts with cells in the body They hope these studies will help them find better ways to treat S aureus infections
Staphylococcus aureus S aureus are bacteria that can make people sick Sometimes an S aureus infection can develop inside the spine these infections can lead to paralysis and death Researchers do not know how S aureus interacts with a person s cells to cause infections in the spine
Objective
To learn how S aureus interacts with cells in the body using tissues from tonsils discarded after standard surgery to remove them
Eligibility
People aged 2 years and older who are scheduled to have their tonsils removed
Design
Researchers will select participants for the study based on review of their existing medical records including results of blood tests any imaging scans including x-rays and reports about tissue specimens
Participants will answer questionnaires about their health and past infections They can do this online or on paper
Participants will collect a nasal swab 1 week before their surgery They will be given a tool that looks like a long cotton swab They will twirl it around inside their nose The swab will pick up cells and fluids that will be used for research
After their surgery the participant s surgeon will save samples of tonsil tissue The surgeon will send these tissue samples and the nasal swab to researchers at the NIH
These tissues and the swab will be used in studies to help researchers understand how S aureus interacts with cells in the body They hope these studies will help them find better ways to treat S aureus infections
Detailed Description:
STUDY DESCRIPTION
The purpose of this study is to collect tonsil tissues that are routinely discarded after tonsillectomy procedures to develop lymphoid organoid models to evaluate host-pathogen interactions in human health and disease One such interaction is the human immunotolerance mechanism to the Chemotaxis Inhibitory Protein of S aureus CHIPS
OBJECTIVES
Primary Objectives
-Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure within the antigenic sin contexts of re-exposure and with repeated exposures to CHIPS
Secondary Objective
-Modulate anti-CHIPS IgG4 class switching through variation of primary and costimulatory signals
ENDPOINTS
Primary Endpoints
Differences between the following within the antigenic sin contexts of re-exposure and with repeated exposures to CHIPS
Immune cell composition
Anti-CHIPS antibody levels including total and subclasses of IgG and their neutralizing capacity
Cytokine levels
Activation-induced cytidine deaminase AID levels
Single-cell inference of class switch recombination sciCSR
Secondary Endpoints
Differences between the following modulation of primary and costimulatory signals
Immune cell composition
Anti-CHIPS antibody levels including total and subclasses of IgG and their neutralizing capacity
Cytokine levels
AID levels
sciCSR
The purpose of this study is to collect tonsil tissues that are routinely discarded after tonsillectomy procedures to develop lymphoid organoid models to evaluate host-pathogen interactions in human health and disease One such interaction is the human immunotolerance mechanism to the Chemotaxis Inhibitory Protein of S aureus CHIPS
OBJECTIVES
Primary Objectives
-Develop a lymphoid organoid model from discarded human tonsils and determine and compare the human immunologic signatures of primary exposure within the antigenic sin contexts of re-exposure and with repeated exposures to CHIPS
Secondary Objective
-Modulate anti-CHIPS IgG4 class switching through variation of primary and costimulatory signals
ENDPOINTS
Primary Endpoints
Differences between the following within the antigenic sin contexts of re-exposure and with repeated exposures to CHIPS
Immune cell composition
Anti-CHIPS antibody levels including total and subclasses of IgG and their neutralizing capacity
Cytokine levels
Activation-induced cytidine deaminase AID levels
Single-cell inference of class switch recombination sciCSR
Secondary Endpoints
Differences between the following modulation of primary and costimulatory signals
Immune cell composition
Anti-CHIPS antibody levels including total and subclasses of IgG and their neutralizing capacity
Cytokine levels
AID levels
sciCSR
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 |
|---|---|---|---|
| 002062-I | None | None | None |