{"id":866,"date":"2025-02-27T14:52:43","date_gmt":"2025-02-27T14:52:43","guid":{"rendered":"http:\/\/centogene.vl22350.dinaserver.com\/?page_id=866"},"modified":"2025-12-23T10:41:55","modified_gmt":"2025-12-23T10:41:55","slug":"amiloidose-hereditaria-relacionada-a-transtirretina-e-monitoramento-longitudinal-de-individuos-ttr-positivos-trammonittr","status":"publish","type":"page","link":"https:\/\/www.centogene.com\/pt\/pharma\/clinical-trial-support\/hereditary-transthyretin-related-amyloidosis-and-longitudinal-monitoring-of-ttr-positive-subjects-trammonittr\/","title":{"rendered":"TRAMmoniTTR"},"content":{"rendered":"<section class=\"bloque-banner-titulo-page  estilo-grey\" id=\"\">\r\n    \r\n    <div class=\"image-wrapper\">\r\n\r\n      <!-- include mp4 video on a loop -->\r\n              <img decoding=\"async\" class=\"\" src=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/csm_centogene-pharma-clinical-trails-tram-header_aef71fdfc5.webp\" alt=\"csm_centogene-pharma-clinical-trails-tram-header_aef71fdfc5\" \/>\r\n          <\/div>\r\n    <div class=\"container content-wrapper\">\r\n      <div class=\"row justify-content-start align-items-center\">\r\n\r\n\r\n        <div class=\"col-12 col-lg-6 animation fadeTop align-self-center\">\r\n                  <h1>TRAMmoniTTR<\/h1>\r\n          <h2 class=\"bl-texto\">Amiloidose heredit\u00e1ria relacionada \u00e0 transtirretina e monitoramento longitudinal de indiv\u00edduos TTR positivos<\/h2>                            <\/div>\r\n\r\n      <\/div>\r\n    <\/div>\r\n\r\n<\/section>\r\n<div class=\"breadcrumbs\">\r\n    <div class=\"container\">\r\n      <div class=\"row\">\r\n        <div class=\"col-12\">\r\n          <ul id=\"breadcrumbs\" class=\"breadcrumbs\"><li><a href=\"https:\/\/www.centogene.com\/pt\/\">Home<\/a><\/li><\/ul>        <\/div>\r\n      <\/div>\r\n    <\/div>\r\n<\/div>\r\n\r\n\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente-my\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\">Resumo<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">O estudo TRAMmoniTTR, que consiste na triagem gen\u00e9tica de uma popula\u00e7\u00e3o de risco para amiloidose heredit\u00e1ria relacionada \u00e0 transtirretina e no monitoramento longitudinal de indiv\u00edduos TTR positivos, \u00e9 um estudo multic\u00eantrico, observacional, epidemiol\u00f3gico e longitudinal.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Vis\u00e3o geral<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">O estudo TRAMmoni <em>TTR<\/em> tem como objetivo investigar a preval\u00eancia da variante ATTR em uma popula\u00e7\u00e3o de risco, monitorar o estado cl\u00ednico em indiv\u00edduos com <em>TTR<\/em> positivo e estabelecer um ou mais biomarcadores para a variante ATTR.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">A amiloidose heredit\u00e1ria por transtirretina \u00e9 uma condi\u00e7\u00e3o autoss\u00f4mica dominante causada por uma variante patog\u00eanica no gene <em>TTR<\/em> (Plante-Bordeneuve et al., 2011), tamb\u00e9m conhecida como ATTRv (variante heredit\u00e1ria da transtirretina). O gene <em>TTR<\/em> codifica a prote\u00edna transtirretina (Ttr), anteriormente conhecida como pr\u00e9-albumina. A transtirretina \u00e9 encontrada principalmente no soro (secretada pelo f\u00edgado) e no l\u00edquido cefalorraquidiano (secretada pelo plexo coroide) e funciona como transportadora do horm\u00f4nio tiroxina (T4) e prote\u00edna ligadora de retinol (ligada ao retinol ou \u00e0 vitamina A). A desestabiliza\u00e7\u00e3o da prote\u00edna Ttr e a forma\u00e7\u00e3o de prote\u00ednas Ttr mal dobradas resultam nas doen\u00e7as de amiloidose por transtirretina.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Em m\u00e9dia, o diagn\u00f3stico \u00e9 atrasado em 4 a 5 anos, especialmente em \u00e1reas n\u00e3o end\u00eamicas. Al\u00e9m disso, o potencial de diagn\u00f3stico incorreto se deve \u00e0 heterogeneidade cl\u00ednica da ATTRv (Adams et al., 2016).<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">    <section class=\"bloque-personalizado bloque-cajas-imgs estilo-cajasblancas\" >\n        <div class=\"\"> \n                        <div class=\"row justify-content-between\">\n\n                                        \n                <div class=\"swiper-slide col-12 delay-1 caja\">\n                    <div class=\"caja-inner\" >\n                        <a href=\"https:\/\/www.centoportal.com\/\" target=\"_blank\" class=\"\">                        <div class=\"bl-imagen animationNo scalexTop delay-1\"><img decoding=\"async\" src=\"https:\/\/www.centogene.com\/wp-content\/uploads\/2025\/02\/csm_centogene-pharma-clinical-trials_study-access-teaser-card_7fbd33e2a0-650x400.webp\" class=\"\" alt=\"\" \/> <\/div>                                               \n                        <\/a>                        \n                        <div class=\"caja-text\">\n                            <p class=\"prefijo\">Ensaios cl\u00ednicos<\/p>                            <h3 class=\"bl-titulo\">Acesso ao estudo no CentoPortal\u00ae para m\u00e9dicos participantes.<\/h3>\n                                  \n                                                          <a target=\"_blank\" href=\"https:\/\/www.centoportal.com\/\" class=\"btn btn-primary\">CentoPortal\u00ae<\/a>\n                                                                          \n                        <\/div>                        \n                        \n                    <\/div>      \n                <\/div>       \n                \n                                     \n             \n            \n        <\/div>\n    <\/div>  \n<\/section>\n\n\n\n<\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    fondocolor\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<h2 class=\"wp-block-heading\">Justificativa e delineamento do estudo<\/h2>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Justificativa do estudo<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">A amiloidose heredit\u00e1ria por transtirretina (ATTRv, amiloidose heredit\u00e1ria relacionada \u00e0 transtirretina) \u00e9 uma condi\u00e7\u00e3o autoss\u00f4mica dominante causada por uma variante patog\u00eanica no gene <em>TTR<\/em> (Plante-Bordeneuve et al. 2011). O gene <em>TTR<\/em> codifica a transtirretina, anteriormente conhecida como pr\u00e9-albumina. A transtirretina ( <em>TTR<\/em> ) \u00e9 encontrada principalmente no soro (secretada pelo f\u00edgado) e no l\u00edquido cefalorraquidiano (secretada pelo plexo coroide) e funciona como transportadora do horm\u00f4nio tiroxina (T4) e da prote\u00edna ligadora de retinol (ligada ao retinol ou \u00e0 vitamina A). A desestabiliza\u00e7\u00e3o da prote\u00edna <em>TTR<\/em> e a forma\u00e7\u00e3o de prote\u00ednas TTR mal dobradas resultam nas doen\u00e7as de amiloidose por transtirretina (ATTRv).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Em m\u00e9dia, o diagn\u00f3stico \u00e9 atrasado em 4 a 5 anos, especialmente em \u00e1reas n\u00e3o end\u00eamicas. Al\u00e9m disso, o potencial de diagn\u00f3stico incorreto se deve \u00e0 heterogeneidade cl\u00ednica da ATTRv (Adams et al., 2016).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Para facilitar o diagn\u00f3stico precoce, a escolha do tratamento e a individualiza\u00e7\u00e3o, os biomarcadores ATTRv s\u00e3o cruciais.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Descubra como voc\u00ea pode participar:\u00a0<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03237494\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Atualmente, n\u00e3o existem op\u00e7\u00f5es de tratamento aprovadas pela FDA dispon\u00edveis para pacientes com ATTRv.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<h3 class=\"wp-block-heading\">Desenho do estudo<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Os pacientes que preencherem os crit\u00e9rios de inclus\u00e3o ser\u00e3o inscritos no estudo. De todos os participantes ser\u00e1 coletada uma \u00fanica amostra de sangue para pesquisa, equivalente a 30 gotas de sangue (aproximadamente 1 ml). A amostra ser\u00e1 aplicada em um...&nbsp;<a href=\"https:\/\/www.centogene.com\/pt\/inovacao\/centocard\/\" data-type=\"page\" data-id=\"1453\">CentoCard<sup>\u00ae<\/sup><\/a>, que ser\u00e1 enviado \u00e0 CENTOGENE e analisado no laborat\u00f3rio da CENTOGENE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">A amostra ser\u00e1 submetida a testes gen\u00e9ticos moleculares por meio do sequenciamento de nova gera\u00e7\u00e3o (NGS) de todo o gene <em>TTR<\/em> .<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>VISITAS TRIMESTRAIS<\/th><th>TEMPO<\/th><th>COLETA DE SANGUE<\/th><th>eCRF<\/th><\/tr><\/thead><tbody><tr><td>V1<\/td><td>0 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V2<\/td><td>3 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V3<\/td><td>6 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V4<\/td><td>9 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V5<\/td><td>12 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V6<\/td><td>15 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V7<\/td><td>18 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V8<\/td><td>21 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><tr><td>V9<\/td><td>24 meses<\/td><td>sim<\/td><td>sim<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">PUBLICA\u00c7\u00c3O DOS RESULTADOS DO ESTUDO TRAM: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/34658264\/\" target=\"_blank\" rel=\"noreferrer noopener\">ANNALS OF MEDICINE; 53:1, 1787-1796. PUBLICADO EM 16 DE OUTUBRO DE 2021.<\/a><\/p>\n<\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente-my\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-8f761849 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<h2 class=\"wp-block-heading\">Informa\u00e7\u00f5es sobre o estudo<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Projeto:<\/strong>&nbsp;Estudo epidemiol\u00f3gico, multic\u00eantrico, internacional e n\u00e3o intervencionista<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Popula\u00e7\u00e3o do estudo:<\/strong>&nbsp;Participantes com risco de amiloidose heredit\u00e1ria por transtirretina (hATTR) e participantes diagnosticados com hATTR.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>N\u00famero de pacientes:&nbsp;<\/strong>5.000 participantes<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Primeiro paciente a entrar:<\/strong>&nbsp;Abril de 2018<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Fim do estudo:<\/strong>&nbsp;Abril de 2025<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Objetivos:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">Monitorar o estado cl\u00ednico em indiv\u00edduos <em>TTR<\/em> positivos.<\/li>\n\n\n\n<li>Investigar a preval\u00eancia de hATTR em uma popula\u00e7\u00e3o de risco.<\/li>\n\n\n\n<li>Para estabelecer o(s) biomarcador(es) hATTR<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Descubra como voc\u00ea pode participar:&nbsp;<a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03237494?term=tram2&amp;rank=1\" target=\"_blank\" rel=\"noreferrer noopener\">ClinicalTrials.gov<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Crit\u00e9rios de inclus\u00e3o<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Crit\u00e9rios de inclus\u00e3o<\/th><\/tr><\/thead><tbody><tr><td>O consentimento informado \u00e9 obtido do participante.<\/td><\/tr><tr><td>O participante tem 18 anos de idade ou mais.<\/td><\/tr><tr><td>O participante n\u00e3o possui diagn\u00f3stico de alcoolismo de acordo com as diretrizes internacionais.<\/td><\/tr><tr><td>O participante n\u00e3o foi submetido a quimioterapia para nenhum tipo de carcinoma.<\/td><\/tr><tr><td>O participante apresenta risco de desenvolver ATTRv devido a dois ou mais dos fatores listados abaixo:<ul class=\"wp-block-list\"><br><li>Cardiomiopatia ou polineuropatia sem etiologia \u00f3bvia<\/li><li>Polineuropatia Desmielinizante Inflamat\u00f3ria Cr\u00f4nica At\u00edpica (PDIC) ou Doen\u00e7a do Neur\u00f4nio Motor (DNM)<\/li><li>Disfun\u00e7\u00e3o auton\u00f4mica<\/li><li>Cardiomiopatia hipertr\u00f3fica ou insufici\u00eancia card\u00edaca com fra\u00e7\u00e3o de eje\u00e7\u00e3o preservada. Hipertrofia ventricular esquerda (HVE).<\/li><li>S\u00edndrome bilateral do t\u00fanel do carpo<\/li><li>Estenose espinhal ou radiculopatia espinhal<\/li><li>Dist\u00farbios da marcha<\/li><li>Altera\u00e7\u00f5es oculares envolvendo opacidades v\u00edtreas<\/li><li>Perda de peso inexplicada superior a 5 kg<\/li><li>Anormalidades renais<\/li><li class=\"translation-block\">Hist\u00f3rico familiar de ATTRv: Com base em exames de imagem ou bi\u00f3psia, suspeita-se de <em>TTR<\/em> do tipo selvagem (ATTR) e n\u00e3o foi realizado teste gen\u00e9tico para ATTRv.<\/li><\/ul>OU<ul class=\"wp-block-list\"><li>O participante foi diagnosticado com ATTRv<\/li><\/ul>OU<ul class=\"wp-block-list\"><li class=\"translation-block\">O participante \u00e9 parente de primeiro ou segundo grau do indiv\u00edduo <em>TTR<\/em> positivo.<\/li><br><\/ul><\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\"><\/div>\n<\/div>\n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    <\/div>\r\n<\/section>\r\n\n\n\r\n    \r\n\r\n<section class=\"bloque-contenedor    transparente\"   id=\"\">\r\n    <div class=\"container\">\r\n        <div class=\"\"> \r\n                                \r\n\r\n                <div class=\"acf-innerblocks-container\">\n  <section class=\"bloque-personalizado bloque-contact-info\" >     \n    <h2 class=\"mt-3 mb-5\"> Entre em contato com o estudo TRAMmoniTTR<\/h2>   \n    <div class=\"row justify-content-center bordesverticales\"> \n        <div class=\"bl-texto col-12 col-md-3\">\n         <h5 class=\"mt-0\">Para obter mais informa\u00e7\u00f5es, entre em contato.<\/h5>\n<p><strong>Dra. Filipa Curado, Gestora S\u00e9nior de Projetos Cl\u00ednicos<\/strong><br \/>\nDepartamento de Estudos Cl\u00ednicos<br \/>\nCENTOGENE GmbH<br \/>\nNa Praia 7<br \/>\n18055 Rostock<br \/>\nAlemanha<br \/>\nE-mail: <a title=\"Escreva um e-mail\" href=\"mailto:filipa.curado@centogene.com\" data-mailto-vector=\"-4\">filipa.curado@centogene.com<\/a><\/p>\n        <\/div>\n        <div class=\"bl-texto  col-12 col-md-2\">\n          \n        <\/div>\n        <div class=\"bl-texto  col-12 col-md-3\">\n          <h5 class=\"mt-0\">Estudos cl\u00ednicos<\/h5>\n<h4>Acesso ao estudo no CentoPortal para m\u00e9dicos participantes.<\/h4>\n<p><a class=\"btn btn-primary\" title=\"CentoPortal\" href=\"https:\/\/login.centoportal.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">CentoPortal<\/a><\/p>\n        <\/div>\n    <\/div>\n  <\/section>  \n\n  \n\n<\/div>\r\n          \r\n                            \r\n        <\/div>\r\n    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