Diagnostic and Therapeutic Applications in Microarrays in Organ Transplantation
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Validation Study of Molecular Diagnostic System, Development of Reporting System for Molecular Diagnosis, Incorporate Molecular Diagnosis Into Diagnostic Standards. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США, Австрия, Канада, Хорватия, Чехия +9
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Multi-centric Observational Study to Analyse the Diagnostic Molecular Features in the Clinical Setting of Kidney Allograft Biopsies
Обзор
The current standard for biopsy-based diagnoses of dysfunction of kidney transplants is the Banff Classification which represents arbitrary international consensus. Recent data-driven approaches using molecular and conventional technologies indicate that mere consensus produces frequently incorrect diagnoses with potential harm to patients due to inappropriate treatment. To address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC) has developed a new diagnostic system that combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The present study will validate and refine this system in 500 prospectively unselected biopsies for clinical indications from American, Canadian and European centres in addition to 300 biopsies already collected. Due to a considerable interest and support from participating Centers, the study is further extended to 1500 prospective biopsies. Thus this is the extension of the INTERCOM study (INTERCOMEX). In addition to demonstrating the feasibility and value of this System in routine patient care and clinical trials, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback on how this system can best improve patient care.
Подробное описание
The study has enrolled so far 3012 biopsies from 2313 participants and the results are analyzed for these biopsies. Follow-up data is, and will be collected.
Первичные конечные точки
- Validate the Integrated Diagnostic System in the International Collaborative Microarray (INTERCOM) Study [Срок оценки: 2013-2016]
Вторичные конечные точки (2)
- Demonstrate the feasibility of molecular phenotyping of 300 + 500 kidney transplant biopsies for clinical indications. [Срок оценки: 2014-2016]
- Demonstrate the feasibility of molecular phenotyping of 500 biopsies in real time i.e. returning the molecular phenotyping report in two working days upon sample arrival. [Срок оценки: 2015-2016]
Критерии участия
Критерии включения
- All kidney transplant recipients ≥18yrs of age undergoing a kidney biopsy for clinical indications, as determined by their physician or surgeon, will be eligible to enrol in the study.
Критерии исключения
- Patients will be excluded from the study if they decline participation or are unable to give informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 10 центров
- University of Alabama — Birmingham
- University of Maryland School of Medicine — Baltimore
- University of Michigan Health System — Ann Arbor
- University of Minnesota — Minneapolis
- Barnes-Jewish Hospital — St Louis
- Montefiore Medical Center — The Bronx
- Pinnacle Transplant Associates — Harrisburg
- Texas Transplant Institute - Methodist Healthcare System — San Antonio
- … и ещё 2 центра
Канада · 2 центра
- Department of Medicine, University of Alberta — Edmonton
- University of British Columbia, St. Paul's Hospital — Vancouver
Франция · 2 центра
- Hopital Necker — Paris
- Hopital St. Louis — Paris
Германия · 2 центра
- Charité - Universitätmedizin Berlin — Berlin
- Medizinische Hochschule — Hanover
Австрия · 1 центр
- Medical University of Vienna — Vienna
Хорватия · 1 центр
- University Hospital Merkur — Zagreb
Чехия · 1 центр
- Institute for Experimental and Clinical Medicine (IKEM) — Prague
Ирландия · 1 центр
- Beaumont Hospital — Dublin
Польша · 1 центр
- Pomeranian Medical University in Szczecin — Szczecin
Словения · 1 центр
- University of Ljubljana — Ljubljana
South Korea · 1 центр
- Department of Surgery, University of Usan, College of Medicine — Seoul
Испания · 1 центр
- Vall d'Hebron Hospital — Barcelona
Швейцария · 1 центр
- University Hospital Zurich — Zurich
Великобритания · 1 центр
- Manchester Royal Infirmary — Manchester
Публикации
- Halloran PF, Famulski KS, Reeve J. Molecular assessment of disease states in kidney transplant biopsy samples. Nat Rev Nephrol. 2016 Sep;12(9):534-48. doi: 10.1038/nrneph.2016.85. Epub 2016 Jun 27. PMID 27345248
- Halloran PF, Venner JM, Famulski KS. Comprehensive Analysis of Transcript Changes Associated With Allograft Rejection: Combining Universal and Selective Features. Am J Transplant. 2017 Jul;17(7):1754-1769. doi: 10.1111/ajt.14200. Epub 2017 Feb 25. PMID 28101959
- Halloran PF, Madill-Thomsen KS, Reeve J. The Molecular Phenotype of Kidney Transplants: Insights From the MMDx Project. Transplantation. 2024 Jan 1;108(1):45-71. doi: 10.1097/TP.0000000000004624. Epub 2023 Dec 13. PMID 37310258
- Madill-Thomsen KS, Halloran PF. Precision diagnostics in transplanted organs using microarray-assessed gene expression: concepts and technical methods of the Molecular Microscope(R) Diagnostic System (MMDx). Clin Sci (Lond). 2024 Jun 5;138(11):663-685. doi: 10.1042/CS20220530. PMID 38819301
- Halloran PF, Chang J, Mackova M, Madill-Thomsen KS, Akalin E, Alhamad T, Anand S, Arnol M, Baliga R, Banasik M, Blosser CD, Bohmig G, Brennan D, Bromberg J, Budde K, Chamienia A, Chow K, Ciszek M, de Freitas D, Deborska-Materkowska D, Debska-Slizien A, Djamali A, Domanski L, Durlik M, Einecke G, Eskandary F, Fatica R, Francis I, Fryc J, Gill J, Gill J, Glyda M, Gourishankar S, Gryczman M, Gupta G, PMID 40232852
- Diebold M, Gauthier PT, Mayer KA, Mackova M, Hinze C, Chang J, Patel UD, Schutz E, Jilma B, Schrezenmeier E, Budde K, Bohmig GA, Halloran PF. Effect of felzartamab on the molecular phenotype of antibody-mediated rejection in kidney transplant biopsies. Nat Med. 2025 May;31(5):1668-1676. doi: 10.1038/s41591-025-03653-3. Epub 2025 Apr 29. PMID 40301559
- Callemeyn J, Nava-Sedeno JM, Anglicheau D, Beadle J, Brasen JH, Clahsen-van Groningen MC, Cristoferi I, de Loor H, Deutsch A, Essig M, Gwinner W, Halloran PF, Hesselink DA, Koshy P, Kuypers D, Lerut E, Marquet P, Minnee RC, Roufosse C, Sprangers B, Van Craenenbroeck AH, Hatzikirou H, Naesens M. Identification and Cross-Platform Validation of Sparse Molecular Classifiers for Antibody-Mediated and T PMID 40630324
- Halloran PF, Pereira AB, Chang J, Matas A, Picton M, De Freitas D, Bromberg J, Seron D, Sellares J, Einecke G, Reeve J. Potential impact of microarray diagnosis of T cell-mediated rejection in kidney transplants: The INTERCOM study. Am J Transplant. 2013 Sep;13(9):2352-63. doi: 10.1111/ajt.12387. Epub 2013 Aug 5. PMID 23915426
Идентификаторы
NCT: NCT01299168 · ATAGC-001