Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-05 @ 6:18 PM
Study NCT ID:
NCT03193151
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2017-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Biopsy extract containing RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2017-06-15', 'studyFirstSubmitQcDate': '2017-06-15', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assign molecular scores (probability) of T cell mediated rejection, antibody mediated rejection in liver transplant biopsies, in a reference set of 100 biopsies', 'timeFrame': 'two years', 'description': 'Based on the reference set, create molecular classifier that predicts antibody mediated and T cell mediated rejection for next 200 biopsies'}], 'secondaryOutcomes': [{'measure': 'Assign in real time (two working days upon biopsy receipt) molecular scores (probability) of T cell mediated rejection and antibody mediated rejection.', 'timeFrame': '1 year', 'description': 'The molecular phenotype of a newly acquired sample predicts the histologic and clinical features of this sample when compared to the reference set.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Liver transplant', 'global gene expression', 'molecular diagnostics'], 'conditions': ['Liver Dysfunction']}, 'referencesModule': {'references': [{'pmid': '38819301', 'type': 'BACKGROUND', 'citation': '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': '39780312', 'type': 'RESULT', 'citation': 'Madill-Thomsen KS, Gauthier PT, Abouljoud M, Bhati C, Bruno D, Ciszek M, Durlik M, Feng S, Foroncewicz B, Grat M, Jurczyk K, Levitsky J, McCaughan G, Maluf D, Montano-Loza A, Moonka D, Mucha K, Myslak M, Perkowska-Ptasinska A, Piecha G, Reichman T, Tronina O, Wawrzynowicz-Syczewska M, Zeair S, Halloran PF. Defining an NK Cell-enriched Rejection-like Phenotype in Liver Transplant Biopsies From the INTERLIVER Study. Transplantation. 2025 Aug 1;109(8):1367-1382. doi: 10.1097/TP.0000000000005269. Epub 2025 Jan 9.'}, {'pmid': '32090446', 'type': 'RESULT', 'citation': 'Madill-Thomsen K, Abouljoud M, Bhati C, Ciszek M, Durlik M, Feng S, Foroncewicz B, Francis I, Grat M, Jurczyk K, Klintmalm G, Krasnodebski M, McCaughan G, Miquel R, Montano-Loza A, Moonka D, Mucha K, Myslak M, Paczek L, Perkowska-Ptasinska A, Piecha G, Reichman T, Sanchez-Fueyo A, Tronina O, Wawrzynowicz-Syczewska M, Wiecek A, Zieniewicz K, Halloran PF. The molecular diagnosis of rejection in liver transplant biopsies: First results of the INTERLIVER study. Am J Transplant. 2020 Aug;20(8):2156-2172. doi: 10.1111/ajt.15828. Epub 2020 Apr 9.'}, {'pmid': '34780106', 'type': 'RESULT', 'citation': 'Madill-Thomsen KS, Abouljoud M, Bhati C, Ciszek M, Durlik M, Feng S, Foroncewicz B, Francis I, Grat M, Jurczyk K, Klintmalm G, Krasnodebski M, McCaughan G, Miquel R, Montano-Loza A, Moonka D, Mucha K, Myslak M, Paczek L, Perkowska-Ptasinska A, Piecha G, Reichman T, Sanchez-Fueyo A, Tronina O, Wawrzynowicz-Syczewska M, Wiecek A, Zieniewicz K, Halloran PF. The molecular phenotypes of injury, steatohepatitis, and fibrosis in liver transplant biopsies in the INTERLIVER study. Am J Transplant. 2022 Mar;22(3):909-926. doi: 10.1111/ajt.16890. Epub 2021 Dec 3.'}, {'pmid': '33595110', 'type': 'DERIVED', 'citation': 'Halloran PF. Integrating molecular and histologic interpretation of transplant biopsies. Clin Transplant. 2021 Apr;35(4):e14244. doi: 10.1111/ctr.14244. Epub 2021 Feb 17. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'INTERLIVER is a prospective observational study of the relationship of the molecular phenotype of 300 liver transplant biopsies to the histologic phenotype and the clinical features and outcomes. A segment of a biopsy performed as standard-of-care for indications, or by center protocol, will be used for gene expression study.', 'detailedDescription': 'The current standard for biopsy-based diagnoses of dysfunction of liver transplants is histology (the Banff system), an arbitrary international empirical consensus based on lesions and rules, similar in principle to the kidney, heart, and lung histology systems. Recent data-driven approaches using molecular and conventional technologies indicate that such systems frequently produce incorrect diagnoses - perhaps 40-50% in abnormal kidney or heart transplant biopsies and even more in lung biopsies, with great potential for harm to patients due to inappropriate treatment.\n\nTo address this unmet need and improve diagnostics in the area of organ transplantation, the Alberta Transplant Applied Genomics Centre (ATAGC, University of Alberta) has developed a new diagnostic system - the Molecular Microscope® Diagnostic System (MMDx) that interprets biopsies in terms of their molecular phenotype, and combines the molecular and histopathological features of transplant biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. The MMDx, developed first in kidney transplant biopsies because phenotypes are well established, will now be adapted to liver transplant biopsies. The present study will develop a Reference Set of liver biopsies, adapt the MMDx system to assess and report molecular phenotype of liver biopsies; and validate and refine this system in 300 unselected prospectively collected for clinical indications and a standard of care biopsies from North American and European Centers. In addition to demonstrating the real-time feasibility and potential value of this System in patient care, the study will develop and optimize a transparent and user-friendly reporting format to communicate this information to clinicians and obtain detailed feedback to improve its utility.\n\nThanks to increasing interest and support from participating centers, INTERLIVER has already received 856 biopsies from 740 participants and will extend the Reference Set to 900 biopsies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to recruit 300 biopsies from liver transplant patients for clinical indications and the standard of care biopsies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy for clinical indications\n\nExclusion Criteria:\n\n* no consent, pregnant women'}, 'identificationModule': {'nctId': 'NCT03193151', 'acronym': 'INTERLIVER', 'briefTitle': 'Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Diagnostic and Therapeutic Applications of Microarrays in Liver Transplantation, a Multicenter Study', 'orgStudyIdInfo': {'id': 'ATAGC04'}}, 'armsInterventionsModule': {'interventions': [{'name': 'liver biopsy', 'type': 'PROCEDURE', 'description': '5 mm fragment of liver transplant biopsy taken for clinical indication'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of California San Francisco, Transplant Research Unit', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dilip Moonka, MD', 'role': 'CONTACT', 'email': 'DMOONKA1@hfhs.org'}, {'name': 'Sierra Foley', 'role': 'CONTACT', 'email': 'SFoley3@hfhs.org'}, {'name': 'Marwan Abouljoud, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Henry Ford Transplant Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center, Vanderbilt Transplant Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Baylor University Medical Center, Annette C. and Harold C. Simmons Transplant Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Transplant Surgery, VCU Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Division of Transplant Surgery, University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'NSW 2050', 'city': 'Camperdown', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Centenary Institute of Cancer Medicine & Cell Biology, Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': 'T6G 2R7', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'University of Alberta, Laboratory Medicine and Pathology', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': '40-027', 'city': 'Katowice', 'status': 'COMPLETED', 'country': 'Poland', 'facility': 'Dep. of Nephrology, Transplantation & Internal Med., Samodzielny Publiczny Szpital Kliniczny im. A. Mieleckiego', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '71-455', 'city': 'Szczecin', 'status': 'COMPLETED', 'country': 'Poland', 'facility': 'Independent Public Composite Regional Hospital', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '02-005', 'city': 'Warsaw', 'status': 'COMPLETED', 'country': 'Poland', 'facility': 'Warsaw Medical University, Jesus the Child Clinical Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '02-097', 'city': 'Warsaw', 'status': 'COMPLETED', 'country': 'Poland', 'facility': 'Warsaw Medical University, Independent Public Clinical Hospital', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': 'SE5 9NU', 'city': 'London', 'status': 'COMPLETED', 'country': 'United Kingdom', 'facility': "Institute for Liver Science, King's College London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Konrad S Famulski, PhD', 'role': 'CONTACT', 'email': 'konrad@ualberta.ca', 'phone': '1 780 492 1725'}, {'name': 'Robert Polakowski, PhD', 'role': 'CONTACT', 'email': 'polakows@ualberta.ca', 'phone': '1 780 492 5091'}], 'overallOfficials': [{'name': 'Philip F Halloran, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alberta'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Distinguished Professor', 'investigatorFullName': 'Philip Halloran', 'investigatorAffiliation': 'University of Alberta'}}}}