- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03397238
Myeloid Cell Reprogramming in Thyroid Carcinoma
Myeloid Cell Reprogramming in the Context of Radioiodine Therapy in Patients With Non-Medullary Thyroid Carcinoma
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Description of the problem:
Non-medullary thyroid carcinoma (TC) is the most common endocrine malignancy and its incidence is one of the most rapidly increasing among the cancer types. For many patients with advanced and poorly differentiated tumors, treatment options are limited and the prognosis of advanced stage metastatic disease remains poor.
Envisioned solution/research direction:
To improve the patients outcome and identify novel therapeutic targets, one needs a 'systems understanding' of the pathophysiology of tumors, particularly the complex interaction of the malignant cells with other cell types in the tumor en the tumor environment (TME), especially immune cells. Tumor-associated macrophages (TAMs), the most dominant myeloid population in aggressive thyroid tumors, exhibit a distorted phenotype functioning predominantly as tumor enhancer. Despite the progress in understanding the importance of TAMs, the in-depth characterization of different TAMs populations is lacking and the mechanisms governing the functional polarization of TAMs are largely unknown. Understanding the interplay between TAMs and tumor cells represents a crucial step towards development of additional therapeutic strategies in cancer.
Hypothesis:
- We first propose that in advanced TC, not only TAMs, but also circulating monocytes and bone marrow (BM) myeloid progenitors are functionally reprogrammed by tumor-derived factors even before their recruitment in the TME.
- Radioactive iodide (I131)(RAI) is a very effective therapy for patients with TC, but is less effective in patients with advanced, metastatic tumors. We hypothesize that by exposing tumor antigens to the immune system, RAI might induce immunogenic effects at the level of the TME with reprogramming of both TAMs present in the TME and circulating monocytes, towards a tumor suppressive phenotype. This may further potentiate the effects of RAI. In addition this could be explored in the future as a basis for immunotherapy for tumors that are refractory to conventional treatment.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Nijmegen, Países Bajos, 6525GA
- Radboudumc
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Group 1:
Subject is newly diagnosed with TC, therapy-naive and is planned to receive conventional treatment by surgery followed by RAI; no evidence of local or distant metastases
- Group 2:
Subject has TC with evidence of distant metastases (either newly diagnosed or therapy-naive or patients with persistent or recurrent disease); at least 4 months since the previous treatment with RAI if applicable
- Group 3:
Subject is diagnosed with MNG, is euthyroid, and is planned to undergo surgery - Group 4: Subject is diagnosed with MNG, is euthyroid, and is planned to receive RAI treatment
- Group 5: Healthy individuals who are euthyroid and have no evidence of thyroid disease
Exclusion Criteria:
- Mentally incompetent
- Pregnant, trying to become pregnant or breastfeeding
- Known inflammatory or infectious diseases or an immunosuppressive status
- Using medication interfering with the immune system
- Reduced platelet counts or other conditions associated with an increased risk of bleeding
- Severe comorbidities: other active malignancy (except for basal cell carcinoma)
- Serious psychiatric pathology
- A self-reported alcohol consumption of >21 units per week
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Non-metastatic TC
blood withdrawal, bone marrow aspiration
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Metastatic TC
blood withdrawal, bone marrow aspiration
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MNG surgery
blood withdrawal, bone marrow aspiration
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MNG RAI treatment
blood withdrawal
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Healthy volunteers
blood withdrawal
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Transcriptional reprogramming of myeloid cells
Periodo de tiempo: baseline
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RNAseq
|
baseline
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Epigenetic reprogramming of myeloid cells
Periodo de tiempo: baseline
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ATAC-seq
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baseline
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Functional reprogramming of myeloid cells
Periodo de tiempo: baseline
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Cytokine response
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baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Metabolites
Periodo de tiempo: baseline
|
Presence and level metabolites
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baseline
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Change of reprogramming after RAI treatment
Periodo de tiempo: baseline and 7 days after RAI treatment
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RNAseq
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baseline and 7 days after RAI treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Romana T Netea-Maier, Endocrinologist
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL62671.091.17
- 2017-3628 (Otro identificador: CMO Arnhem-Nijmegen)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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