- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07639996
Natural Course and Molecular Basis of Alpha 1- Antitrypsin Deficiency-associated Liver Disease.
- To define the course of AATD-associated liver disease.
To use the obtained samples for biomedical research which includes:
- Search for serum-based disease biomarkers and the associated molecular pathways.
- Multi-omic spatial analysis of human AATD-LD.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
AATD is one of the most common, potentially lethal genetic conditions and results from mutations in alpha-1 antitrypsin (AAT), an abundant serine protease inhibitor (SERPIN) produced primarily in hepatocytes. The majority of severe AATD cases result from a homozygous PiZ mutation termed PiZZ that leads to a rapid polymerization of the mutated protein and its retention in the endoplasmic reticulum (ER) of hepatocytes. The consecutive lack of AAT in circulation increases proteolytic digestion of lung tissue and predisposes to chronic obstructive pulmonary disease and lung emphysema. The hepatic AAT misfolding confers a proteotoxic stress and may lead to both pediatric and adult liver disease (pAATD-LD/aAATD-LD). The former becomes apparent as neonatal jaundice and constitutes one of the most common causes of pediatric liver transplantation while the latter emerges mostly at >40 years of age as significant liver fibrosis and occurs more frequently in subjects with metabolic risk factors such as obesity and diabetes mellitus.
Much less is known about pAATD-LD that is considered a more cholestatic condition with less obvious AAT accumulation. Moreover, the exact relationship between AAT accumulation and development of AATD-LD remains unclear.
A major obstacle when studying AATD-LD is the lack of a suitable experimental model system. While transgenic animals overexpressing PiZ have been widely used, they have several disadvantages such as presence of multiple PiZ copies as well as inability to reproduce pAATD-LD. To circumvent that, analyses of human specimen as well as human induced pluripotent stem cells (iPSC) derived hepatocyte like cells (HLCs) are essential. Therefore, our research aims to obtain further insights into the process of AAT accumulation as well as to delineate the mechanistic differences between pediatric and adult AATD-LD.
Typ studiów
Zapisy (Szacowany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
- Adult patients (≥18 years) with genetically confirmed alpha-1 antitrypsin deficiency (Pi*ZZ genotype).
- Availability of longitudinal clinical follow-up data (minimum 5 years) within the AATD consortium.
- At least one documented liver assessment including liver stiffness measurement (LSM) and serum-based fibrosis markers.
- Availability of stored serum samples for proteomic analysis.
- For translational analyses: availability of liver tissue samples (pediatric or adult) and/or induced pluripotent stem cell (iPSC)-derived hepatocyte-like cells.
Opis
Inclusion Criteria:
- Adult patients (≥18 years) with genetically confirmed alpha-1 antitrypsin deficiency (Pi*ZZ genotype).
- Availability of longitudinal clinical follow-up data (minimum 5 years) within the AATD consortium.
- At least one documented liver assessment including liver stiffness measurement (LSM) and serum-based fibrosis markers.
- Availability of stored serum samples for proteomic analysis.
- For translational analyses: availability of liver tissue samples (pediatric or adult) and/or induced pluripotent stem cell (iPSC)-derived hepatocyte-like cells.
Exclusion Criteria:
- Presence of other chronic liver diseases (e.g., viral hepatitis, autoimmune hepatitis) that may confound fibrosis assessment.
- History of liver transplantation prior to study inclusion.
- Incomplete clinical, laboratory, or follow-up data.
- Poor-quality or insufficient biological samples for proteomic or molecular analyses.
- Patients lost to follow-up or with unreliable longitudinal data
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
Search for serum-based disease biomarkers and the associated molecular pathways
Ramy czasowe: Eight months of performing serum proteomics to identify biomarkers that reflect liver disease severity and predict poor outcomes
|
Eight months of performing serum proteomics to identify biomarkers that reflect liver disease severity and predict poor outcomes
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
Multi-omic spatial analysis of human AATD-LD.
Ramy czasowe: Eight months of conduction of spatial multi-omic analyses comparing pediatric and adult liver tissues. This will include proteomic and transcriptomic mapping to understand how AAT accumulation and ductular reactions differ between the two forms.
|
Eight months of conduction of spatial multi-omic analyses comparing pediatric and adult liver tissues. This will include proteomic and transcriptomic mapping to understand how AAT accumulation and ductular reactions differ between the two forms.
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Townsend SA, Edgar RG, Ellis PR, Kantas D, Newsome PN, Turner AM. Systematic review: the natural history of alpha-1 antitrypsin deficiency, and associated liver disease. Aliment Pharmacol Ther. 2018 Apr;47(7):877-885. doi: 10.1111/apt.14537. Epub 2018 Feb 15.
- Tafaleng EN, Chakraborty S, Han B, Hale P, Wu W, Soto-Gutierrez A, Feghali-Bostwick CA, Wilson AA, Kotton DN, Nagaya M, Strom SC, Roy-Chowdhury J, Stolz DB, Perlmutter DH, Fox IJ. Induced pluripotent stem cells model personalized variations in liver disease resulting from alpha1-antitrypsin deficiency. Hepatology. 2015 Jul;62(1):147-57. doi: 10.1002/hep.27753. Epub 2015 Apr 13.
- Strnad P, McElvaney NG, Lomas DA. Alpha1-Antitrypsin Deficiency. N Engl J Med. 2020 Apr 9;382(15):1443-1455. doi: 10.1056/NEJMra1910234. No abstract available.
- Ruiz M, Lacaille F, Schrader C, Pons M, Socha P, Krag A, Sturm E, Bouchecareilh M, Strnad P. Pediatric and Adult Liver Disease in Alpha-1 Antitrypsin Deficiency. Semin Liver Dis. 2023 Aug;43(3):258-266. doi: 10.1055/a-2122-7674. Epub 2023 Jul 4.
- Patel D, McAllister SL, Teckman JH. Alpha-1 antitrypsin deficiency liver disease. Transl Gastroenterol Hepatol. 2021 Apr 5;6:23. doi: 10.21037/tgh.2020.02.23. eCollection 2021.
- Ncube A, Bewersdorf L, Spitzhorn LS, Loerch C, Bohndorf M, Graffmann N, May L, Amzou S, Fromme M, Wruck W, Strnad P, Adjaye J. Generation of two Alpha-I antitrypsin deficiency patient-derived induced pluripotent stem cell lines ISRM-AATD-iPSC-1 (HHUUKDi011-A) and ISRM-AATD-iPSC-2 (HHUUKDi012-A). Stem Cell Res. 2023 Sep;71:103171. doi: 10.1016/j.scr.2023.103171. Epub 2023 Jul 23.
- Kaserman JE, Hurley K, Dodge M, Villacorta-Martin C, Vedaie M, Jean JC, Liberti DC, James MF, Higgins MI, Lee NJ, Washko GR, San Jose Estepar R, Teckman J, Kotton DN, Wilson AA. A Highly Phenotyped Open Access Repository of Alpha-1 Antitrypsin Deficiency Pluripotent Stem Cells. Stem Cell Reports. 2020 Jul 14;15(1):242-255. doi: 10.1016/j.stemcr.2020.06.006. Epub 2020 Jul 2.
- Hamesch K, Mandorfer M, Pereira VM, Moeller LS, Pons M, Dolman GE, Reichert MC, Schneider CV, Woditsch V, Voss J, Lindhauer C, Fromme M, Spivak I, Guldiken N, Zhou B, Arslanow A, Schaefer B, Zoller H, Aigner E, Reiberger T, Wetzel M, Siegmund B, Simoes C, Gaspar R, Maia L, Costa D, Bento-Miranda M, van Helden J, Yagmur E, Bzdok D, Stolk J, Gleiber W, Knipel V, Windisch W, Mahadeva R, Bals R, Koczulla R, Barrecheguren M, Miravitlles M, Janciauskiene S, Stickel F, Lammert F, Liberal R, Genesca J, Griffiths WJ, Trauner M, Krag A, Trautwein C, Strnad P; European Alpha1-Liver Study Group. Liver Fibrosis and Metabolic Alterations in Adults With alpha-1-antitrypsin Deficiency Caused by the Pi*ZZ Mutation. Gastroenterology. 2019 Sep;157(3):705-719.e18. doi: 10.1053/j.gastro.2019.05.013. Epub 2019 May 20.
- Greene CM, Marciniak SJ, Teckman J, Ferrarotti I, Brantly ML, Lomas DA, Stoller JK, McElvaney NG. alpha1-Antitrypsin deficiency. Nat Rev Dis Primers. 2016 Jul 28;2:16051. doi: 10.1038/nrdp.2016.51.
- Fromme M, Schneider CV, Trautwein C, Brunetti-Pierri N, Strnad P. Alpha-1 antitrypsin deficiency: A re-surfacing adult liver disorder. J Hepatol. 2022 Apr;76(4):946-958. doi: 10.1016/j.jhep.2021.11.022. Epub 2021 Nov 27.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Alpha 1 antitrypsin deficiency
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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Badania kliniczne na Multi-omic spatial analysis
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Cancer Institute and Hospital, Chinese Academy...Jeszcze nie rekrutacja