Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- Observacional
- Fase
- No aplica / no indicada
- Rango de edad
- 2 años - 120 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 500 Estimado
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
- INCLUSION CRITERIA:
To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged \>=2 yrs.
- Undergoing tonsillectomy as part of their clinical care.
- Able to provide informed consent (for ages \>=18 years) or has a parent or guardian who can provide informed consent on their behalf (for ages \<18 yrs).
- Willing to allow samples and data to be stored and shared for future secondary research.
- Willing to allow future genetic testing on their biospecimens.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Active infection.
- Active tonsilitis.
- Pregnant.
- Diagnosed with an immunosuppressive condition or currently taking immunosuppressive medications.
- Current or past intravenous drug use.
- Any condition that, in the judgment of the investigator, may put the participant at undue risk or make them unsuitable for participation in the study
Población del estudio
Patients undergoing tonsillectomy as part of their clinical care at hospitals and pediatric ear nose and throat (ENT) practices in the US will be enrolled.
Entiende la evaluación inicialTratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No informado
- Enmascaramiento
- No informado
Tonsillectomy Patients
Patients undergoing tonsillectomy as part of their clinical care
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Immune cell composition
Plazo: At time of collection
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.
Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity
Plazo: At time of collection
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.
Cytokine levels
Plazo: At time of collection
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.
Activation-induced cytidine deaminase (AID) levels
Plazo: At time of collection
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.
Single-cell inference of class switch recombination (sciCSR)
Plazo: At time of collection
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.
Medidas secundarias
Immune cell composition
Plazo: At time of collection
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Anti-CHIPS antibody levels, including total and subclasses of IgG and their neutralizing capacity
Plazo: At time of collection
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Cytokine levels
Plazo: At time of collection
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Activation-induced cytidine deaminase (AID) levels
Plazo: At time of collection
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Single-cell inference of class switch recombination (sciCSR)
Plazo: At time of collection
Primary signals such as antigen characteristics, and secondary signals such as cytokines have been implicated in class switching to IgG4 but have not been defined with respect to CHIPS. Varying these signals and evaluating: 1) organoid immune cell composition, 2) antibody and 3) cytokines levels, and indicators of class switching such as 4) AID and 5) sciCSR levels, will enable us to evaluate modulation of human immunotolerance to CHIPS.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (2)
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2 centros
National Institute of Allergy and Infectious Diseases (NIAID)Bethesda, Maryland, United StatesReclutando
National Institutes of Health Clinical CenterBethesda, Maryland, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- National Institute of Allergy and Infectious Diseases (NIAID)
- Inicio del estudio
- 15 nov 2026 Estimado
- Finalización primaria
- 1 dic 2043 Estimado
- Finalización del estudio
- 1 dic 2044 Estimado
- Primera publicación
- 28 jun 2024 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026