{"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":"dziedziczna-amyloidoza-zwiazana-z-transtyretyna-i-dlugoterminowe-monitorowanie-osob-z-dodatnim-wynikiem-testu-ttr","status":"publish","type":"page","link":"https:\/\/www.centogene.com\/pl\/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\">Dziedziczna amyloidoza zwi\u0105zana z transtyretyn\u0105 i d\u0142ugoterminowe monitorowanie os\u00f3b z dodatnim wynikiem TTR<\/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\/pl\/\">Dom<\/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\">Streszczenie<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Badanie TRAMmoniTTR, kt\u00f3rego celem jest genetyczne badanie przesiewowe populacji zagro\u017conej dziedziczn\u0105 amyloidoz\u0105 zwi\u0105zan\u0105 z transtyretyn\u0105 oraz d\u0142ugofalowe monitorowanie os\u00f3b z dodatnim wynikiem TTR, to wieloo\u015brodkowe, obserwacyjne, epidemiologiczne badanie d\u0142ugofalowe<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Przegl\u0105d<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Badanie TRAMmoni <em>TTR<\/em> ma na celu zbadanie cz\u0119sto\u015bci wyst\u0119powania ATTRv w populacji ryzyka, monitorowanie stanu klinicznego os\u00f3b z dodatnim wynikiem <em>TTR<\/em> i okre\u015blenie biomarker\u00f3w ATTRv.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Dziedziczna amyloidoza transtyretynowa to choroba dziedziczona autosomalnie dominuj\u0105co, spowodowana patogennym wariantem genu <em>TTR<\/em> (Plante-Bordeneuve i in. 2011), znanym r\u00f3wnie\u017c jako ATTRv (wariant transtyretyny w amyloidozie dziedzicznej). Gen <em>TTR<\/em> koduje bia\u0142ko transtyretyny (Ttr), dawniej znane jako prealbumina. Transtyretyna wyst\u0119puje g\u0142\u00f3wnie w surowicy (wydzielana przez w\u0105trob\u0119) oraz p\u0142ynie m\u00f3zgowo-rdzeniowym (wydzielana przez splot naczyni\u00f3wkowy) i pe\u0142ni funkcj\u0119 no\u015bnika, *transportu* hormonu *tyroksyny (T4) oraz bia\u0142ka wi\u0105\u017c\u0105cego *retinol* (zwi\u0105zanego z retinolem lub witamin\u0105 A). Destabilizacja bia\u0142ka Ttr i powstawanie nieprawid\u0142owo sfa\u0142dowanych bia\u0142ek Ttr prowadzi do amyloidozy transtyretynowej.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u015arednio diagnoza jest op\u00f3\u017aniona o 4\u20135 lat, szczeg\u00f3lnie na obszarach nieendemicznych. Ponadto, potencjalne b\u0142\u0119dne rozpoznanie wynika z heterogeniczno\u015bci klinicznej ATTRv (Adams i in., 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\">Badania kliniczne<\/p>                            <h3 class=\"bl-titulo\">Dost\u0119p do bada\u0144 na CentoPortal\u00ae dla uczestnicz\u0105cych lekarzy<\/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\">Uzasadnienie i projekt badania<\/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\">Uzasadnienie badania<\/h3>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Dziedziczna amyloidoza transtyretynowa (ATTRv, dziedziczna amyloidoza, zwi\u0105zana z transtyretyn\u0105) jest chorob\u0105 dziedziczon\u0105 autosomalnie dominuj\u0105co, spowodowan\u0105 patogennym wariantem genu <em>TTR<\/em> (Plante-Bordeneuve i in. 2011). Gen <em>TTR<\/em> koduje transtyretyn\u0119, dawniej znan\u0105 jako prealbumina. Transtyretyna ( <em>TTR<\/em> ) wyst\u0119puje g\u0142\u00f3wnie w surowicy (wydzielana przez w\u0105trob\u0119) oraz p\u0142ynie m\u00f3zgowo-rdzeniowym (wydzielana przez splot naczyni\u00f3wkowy) i pe\u0142ni funkcj\u0119 no\u015bnika dla hormonu tyroksyny (T4) oraz bia\u0142ka wi\u0105\u017c\u0105cego retinol (zwi\u0105zanego z retinolem lub witamin\u0105 A). Destabilizacja bia\u0142ka <em>TTR<\/em> i powstawanie nieprawid\u0142owo sfa\u0142dowanych bia\u0142ek Ttr prowadzi do amyloidozy transtyretynowej (ATTRv).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u015arednio diagnoza jest op\u00f3\u017aniona o 4\u20135 lat, szczeg\u00f3lnie na obszarach nieendemicznych. Ponadto, potencjalne b\u0142\u0119dne rozpoznanie wynika z heterogeniczno\u015bci klinicznej ATTRv (Adams i in., 2016).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Aby u\u0142atwi\u0107 wczesn\u0105 diagnoz\u0119, wyb\u00f3r leczenia i indywidualizacj\u0119, kluczowe znaczenie maj\u0105 biomarkery ATTRv.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dowiedz si\u0119, jak mo\u017cesz wzi\u0105\u0107 udzia\u0142:\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\">Obecnie nie ma zatwierdzonych przez FDA opcji leczenia dost\u0119pnych dla pacjent\u00f3w z 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\">Projekt badania<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Pacjenci spe\u0142niaj\u0105cy kryteria w\u0142\u0105czenia zostan\u0105 w\u0142\u0105czeni do badania. Od ka\u017cdego uczestnika zostanie pobrana jedna pr\u00f3bka krwi do bada\u0144, odpowiadaj\u0105ca 30 kroplom krwi (oko\u0142o 1 ml). Pr\u00f3bka zostanie naniesiona na&nbsp;<a href=\"https:\/\/www.centogene.com\/pl\/innovation\/centocard\/\" data-type=\"page\" data-id=\"1453\">CentoCard<sup>\u00ae<\/sup><\/a>, kt\u00f3re zostan\u0105 przes\u0142ane do CENTOGENE i przeanalizowane w laboratorium CENTOGENE.<\/p>\n\n\n\n<p class=\"wp-block-paragraph translation-block\">Pr\u00f3bka zostanie poddana badaniom genetyczno-molekularnym przy u\u017cyciu sekwencjonowania ca\u0142ego genu <em>TTR<\/em> opartego na NGS.<\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>WIZYTY KWARTALNE<\/th><th>CZAS<\/th><th>POBIERANIE KRWI<\/th><th>eCRF<\/th><\/tr><\/thead><tbody><tr><td>Wersja 1<\/td><td>0 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 2<\/td><td>3 miesi\u0105ce<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 3<\/td><td>6 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 4<\/td><td>9 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 5<\/td><td>12 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 6<\/td><td>15 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 7<\/td><td>18 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>V8<\/td><td>21 miesi\u0119cy<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><tr><td>Wersja 9<\/td><td>24 miesi\u0105ce<\/td><td>Tak<\/td><td>Tak<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">PUBLIKACJA WYNIK\u00d3W BADANIA TRAM: <a href=\"https:\/\/pubmed.ncbi.nlm.nih.gov\/34658264\/\" target=\"_blank\" rel=\"noreferrer noopener\">ANNALS OF MEDICINE; 53:1, 1787-1796. OPUBLIKOWANO 16 PA\u0179DZIERNIKA 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\">Informacje o badaniu<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Projekt:<\/strong>&nbsp;Badanie epidemiologiczne, wieloo\u015brodkowe, mi\u0119dzynarodowe i nieinterwencyjne<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Populacja badana:<\/strong>&nbsp;Uczestnicy nara\u017ceni na dziedziczn\u0105 amyloidoz\u0119 transtyretynow\u0105 (hATTR) oraz uczestnicy zdiagnozowani z hATTR<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Liczba pacjent\u00f3w:&nbsp;<\/strong>5000 uczestnik\u00f3w<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Pierwszy pacjent w:<\/strong>&nbsp;Kwiecie\u0144 2018<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Koniec nauki:<\/strong>&nbsp;Kwiecie\u0144 2025<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Cele:<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li class=\"translation-block\">Monitorowanie stanu klinicznego u os\u00f3b z dodatnim wynikiem <em>testu TTR<\/em><\/li>\n\n\n\n<li>Zbadanie cz\u0119sto\u015bci wyst\u0119powania hATTR w populacji zagro\u017conej<\/li>\n\n\n\n<li>Aby ustali\u0107 biomarker\/y hATTR<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">Dowiedz si\u0119, jak mo\u017cesz wzi\u0105\u0107 udzia\u0142:&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\">Kryteria w\u0142\u0105czenia<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Kryteria w\u0142\u0105czenia<\/th><\/tr><\/thead><tbody><tr><td>Uzyskano \u015bwiadom\u0105 zgod\u0119 uczestnika<\/td><\/tr><tr><td>Uczestnik ma uko\u0144czone 18 lat<\/td><\/tr><tr><td>Uczestnik nie ma diagnozy alkoholizmu zgodnie z mi\u0119dzynarodowymi wytycznymi<\/td><\/tr><tr><td>Uczestnik nie przechodzi\u0142 chemioterapii z powodu \u017cadnego nowotworu<\/td><\/tr><tr><td>Uczestnik jest nara\u017cony na ryzyko wyst\u0105pienia ATTRv z powodu co najmniej dw\u00f3ch czynnik\u00f3w wymienionych poni\u017cej:<ul class=\"wp-block-list\"><br><li>Kardiomiopatia lub polineuropatia bez wyra\u017anej etiologii<\/li><li>Nietypowa przewlek\u0142a zapalna polineuropatia demielinizacyjna (CIDP) lub choroba neuronu ruchowego (MND)<\/li><li>Dysfunkcja autonomiczna<\/li><li>Kardiomiopatia przerostowa lub niewydolno\u015b\u0107 serca z zachowan\u0105 frakcj\u0105 wyrzutow\u0105 Przerost lewej komory (LVH)<\/li><li>Zesp\u00f3\u0142 cie\u015bni nadgarstka obustronny<\/li><li>Zw\u0119\u017cenie kana\u0142u kr\u0119gowego lub korzeniowe zapalenie kr\u0119gos\u0142upa<\/li><li>Zaburzenia chodu<\/li><li>Zmiany oczne obejmuj\u0105ce zm\u0119tnienia cia\u0142a szklistego<\/li><li>Niewyja\u015bniona utrata masy cia\u0142a &gt;5 kg<\/li><li>Nieprawid\u0142owo\u015bci nerek<\/li><li class=\"translation-block\">Wywiad rodzinny w kierunku ATTRvNa podstawie bada\u0144 obrazowych lub biopsji podejrzewa si\u0119 obecno\u015b\u0107 dzikiego typu <em>TTR<\/em> (ATTR) i nie wykonano bada\u0144 genetycznych w kierunku ATTRv<\/li><\/ul>LUB<ul class=\"wp-block-list\"><li>U uczestnika zdiagnozowano ATTRv<\/li><\/ul>LUB<ul class=\"wp-block-list\"><li class=\"translation-block\">Uczestnik jest krewnym pierwszego lub drugiego stopnia osoby z pozytywnym wynikiem testu <em>TTR<\/em><\/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\"> Kontakt z badaniem 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\">Aby uzyska\u0107 wi\u0119cej informacji, skontaktuj si\u0119 z nami<\/h5>\n<p><strong>Dr Filipa Curado, Starszy Kierownik Projektu Klinicznego<\/strong><br \/>\nWydzia\u0142 Bada\u0144 Klinicznych<br \/>\nCENTOGENE GmbH<br \/>\nNa pla\u017cy 7<br \/>\n18055 Rostock<br \/>\nNiemcy<br \/>\nE-mail: <a title=\"Napisz 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\">Badania kliniczne<\/h5>\n<h4>Dost\u0119p do bada\u0144 na CentoPortal dla uczestnicz\u0105cych lekarzy<\/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    <\/div>\r\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":1078,"menu_order":30,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-866","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>TRAMmoniTTR | CENTOGENE<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.centogene.com\/pl\/farmaceutyka\/wsparcie-badan-klinicznych\/dziedziczna-amyloidoza-zwiazana-z-transtyretyna-i-dlugoterminowe-monitorowanie-osob-z-dodatnim-wynikiem-testu-ttr\/\" \/>\n<meta property=\"og:locale\" content=\"pl_PL\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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