Q3160431 (Q3160431): Difference between revisions
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(Created claim: summary (P836): The objectives of the study are to: 1) compare the influence of the withdrawal of immunosuppression on the development of clinical complications, 2) study the evolution of different immunological parameters involved in the development of tolerance in blood and liver biopsy (before and after the withdrawal of immunosuppression), 3) Determine the diagnostic accuracy of one or more of these biomarkers to predict the result of the protocolised withd...) |
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The objectives of the study are to: 1) compare the influence of the withdrawal of immunosuppression on the development of clinical complications, 2) study the evolution of different immunological parameters involved in the development of tolerance in blood and liver biopsy (before and after the withdrawal of immunosuppression), 3) Determine the diagnostic accuracy of one or more of these biomarkers to predict the result of the protocolised withdrawal of immunosuppression, 4) To assess the predictive capacity of the lymphocyte stimulation index on the development of tolerance. A prospective, multicenter, randomised, open-label clinical trial will be conducted, including 324 patients who will attempt to remove immunosuppression completely or keep it unchanged. Studies of 1) evolution of peripheral blood mononuclear cell subpopulations, 2) evolution of cytokine production by peripheral blood lymphocytes, 3) lymphocyte proliferation assays (stimulation rate) 4) epigenetic analysis of the degree of demethylation of the TSDR region of the FOXP3 gene at the peripheral and tissue level, 5) study of gene expression profiles and miRNAs in mononuclear cells and liver, 6) immunohistochemical analysis of CD4+FOXp3+ lymphocytes in liver biopsies will be performed periodically. Of these six tasks, the first three belong to the subproject presented by Dr. José Ignacio Herrero Santos and the last three belong to this subproject. The coordination of both will be done by Dr. José Antonio Pons. (English) | |||||||||||||||
| Property / summary: The objectives of the study are to: 1) compare the influence of the withdrawal of immunosuppression on the development of clinical complications, 2) study the evolution of different immunological parameters involved in the development of tolerance in blood and liver biopsy (before and after the withdrawal of immunosuppression), 3) Determine the diagnostic accuracy of one or more of these biomarkers to predict the result of the protocolised withdrawal of immunosuppression, 4) To assess the predictive capacity of the lymphocyte stimulation index on the development of tolerance. A prospective, multicenter, randomised, open-label clinical trial will be conducted, including 324 patients who will attempt to remove immunosuppression completely or keep it unchanged. Studies of 1) evolution of peripheral blood mononuclear cell subpopulations, 2) evolution of cytokine production by peripheral blood lymphocytes, 3) lymphocyte proliferation assays (stimulation rate) 4) epigenetic analysis of the degree of demethylation of the TSDR region of the FOXP3 gene at the peripheral and tissue level, 5) study of gene expression profiles and miRNAs in mononuclear cells and liver, 6) immunohistochemical analysis of CD4+FOXp3+ lymphocytes in liver biopsies will be performed periodically. Of these six tasks, the first three belong to the subproject presented by Dr. José Ignacio Herrero Santos and the last three belong to this subproject. The coordination of both will be done by Dr. José Antonio Pons. (English) / rank | |||||||||||||||
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| Property / summary: The objectives of the study are to: 1) compare the influence of the withdrawal of immunosuppression on the development of clinical complications, 2) study the evolution of different immunological parameters involved in the development of tolerance in blood and liver biopsy (before and after the withdrawal of immunosuppression), 3) Determine the diagnostic accuracy of one or more of these biomarkers to predict the result of the protocolised withdrawal of immunosuppression, 4) To assess the predictive capacity of the lymphocyte stimulation index on the development of tolerance. A prospective, multicenter, randomised, open-label clinical trial will be conducted, including 324 patients who will attempt to remove immunosuppression completely or keep it unchanged. Studies of 1) evolution of peripheral blood mononuclear cell subpopulations, 2) evolution of cytokine production by peripheral blood lymphocytes, 3) lymphocyte proliferation assays (stimulation rate) 4) epigenetic analysis of the degree of demethylation of the TSDR region of the FOXP3 gene at the peripheral and tissue level, 5) study of gene expression profiles and miRNAs in mononuclear cells and liver, 6) immunohistochemical analysis of CD4+FOXp3+ lymphocytes in liver biopsies will be performed periodically. Of these six tasks, the first three belong to the subproject presented by Dr. José Ignacio Herrero Santos and the last three belong to this subproject. The coordination of both will be done by Dr. José Antonio Pons. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 16:42, 12 October 2021
Project Q3160431 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3160431 in Spain |
Statements
101,800.0 Euro
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127,250.0 Euro
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80.0 percent
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1 January 2018
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31 March 2021
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FUNDACION PARA LA FORMACION E INVESTIGACION SANITARIAS DE LA REGION DE MURCIA (FFIS)
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37°59'32.57"N, 1°7'49.94"W
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30030
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Los objetivos del estudio son: 1) comparar la influencia de la retirada de la inmunosupresión en el desarrollo de complicaciones clínicas, 2) estudiar la evolución de distintos parámetros inmunológicos implicados en el desarrollo de tolerancia en sangre y en biopsia hepática (antes y después de la retirada de la inmunosupresión), 3) Determinar la precisión diagnóstica de uno o varios de estos biomarcadores para predecir el resultado de la retirada protocolizada de la inmunosupresión, 4) Valorar la capacidad predicitva del índice de estimulación linfocitaria sobre el desarrollo de tolerancia. Se llevará a cabo un ensayo clínico prospectivo, multicéntrico, aleatorizado, abierto en el que se incluirán 324 pacientes a los que se intentará retirar por completo la inmunosupresión o mantenerla sin cambios. De forma periódica se harán estudios de 1) evolución de subpoblaciones de células mononucleares de sangre periférica, 2) evolución de la producción de citoquinas por los linfocitos de sangre periférica, 3) ensayos de proliferación linfocitaria (índice de estimulación) 4) análisis epigenéticos del grado de desmetilación de la región TSDR del gen FOXP3 a nivel periférico y tejido, 5) estudio de los perfiles de expresión génica y miRNAs en células mononucleares y en hígado, 6) análisis inmunohistoquímico de linfocitos CD4+FOXp3+ en biopsias hepáticas. De estas seis tareas, las tres primeras pertenecen al subproyecto presentado por el Dr. José Ignacio Herrero Santos y las tres últimas pertenecen a este subproyecto. La coordinación de ambos será realizada por el Dr. José Antonio Pons. (Spanish)
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The objectives of the study are to: 1) compare the influence of the withdrawal of immunosuppression on the development of clinical complications, 2) study the evolution of different immunological parameters involved in the development of tolerance in blood and liver biopsy (before and after the withdrawal of immunosuppression), 3) Determine the diagnostic accuracy of one or more of these biomarkers to predict the result of the protocolised withdrawal of immunosuppression, 4) To assess the predictive capacity of the lymphocyte stimulation index on the development of tolerance. A prospective, multicenter, randomised, open-label clinical trial will be conducted, including 324 patients who will attempt to remove immunosuppression completely or keep it unchanged. Studies of 1) evolution of peripheral blood mononuclear cell subpopulations, 2) evolution of cytokine production by peripheral blood lymphocytes, 3) lymphocyte proliferation assays (stimulation rate) 4) epigenetic analysis of the degree of demethylation of the TSDR region of the FOXP3 gene at the peripheral and tissue level, 5) study of gene expression profiles and miRNAs in mononuclear cells and liver, 6) immunohistochemical analysis of CD4+FOXp3+ lymphocytes in liver biopsies will be performed periodically. Of these six tasks, the first three belong to the subproject presented by Dr. José Ignacio Herrero Santos and the last three belong to this subproject. The coordination of both will be done by Dr. José Antonio Pons. (English)
12 October 2021
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Murcia
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Identifiers
PI17_00489
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