Ignite Creation Date:
2025-12-25 @ 1:04 AM
Ignite Modification Date:
2026-01-03 @ 5:52 PM
Study NCT ID:
NCT03301493
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2017-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genomic Testing and Resulting Medical Decisions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009382', 'term': 'Neoplasms, Unknown Primary'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076610', 'term': 'Genetic Profile'}], 'ancestors': [{'id': 'D000068617', 'term': 'Genetic Background'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2017-09-22', 'studyFirstSubmitQcDate': '2017-10-03', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Types of:molecular profiling methods', 'timeFrame': '3 years', 'description': 'To describe types of:molecular profiling methods used in the Austrian registry centres'}, {'measure': 'Types of cancer, for which comprehensive molecular profiling is used', 'timeFrame': '3 years', 'description': 'To describe types of cancer, for which comprehensive molecular profiling is used'}, {'measure': 'Timing of molecular profiling', 'timeFrame': '3 years', 'description': 'To describe the timing of molecular profiling in relation to stage of the disease (e.g. at diagnosis, after surgery, radiation therapy, after first/second/third/late line)'}], 'secondaryOutcomes': [{'measure': 'Number of patients with mutations identified', 'timeFrame': '3 years', 'description': 'To describe targets identified:\n\n* number of patients with at least one mutation identified\n* number of patients with at least one druggable target identified\n* number of patients with more than one druggable targets identified\n* number of druggable targets per cancer type'}, {'measure': 'Quality standards', 'timeFrame': '3 years', 'description': 'To describe tests used and quality standards:\n\n* to compare results of NGS based molecular test systems with single marker tests or small gene panel tests\n* quality standards of the test methods used (TAT, certification status)\n* to evaluate development of methods used over time\n* usage of commercial testing vs. in-house testing, platforms used, and number of genes as well as gene size analyzed (eg whole exome with or without selected intron sequencing vs. hot spot exome sequencing)'}, {'measure': 'Treatment decisions', 'timeFrame': '3 years', 'description': 'To describe treatment decisions:\n\n* frequency by which treatment decision follows the result of NGS testing\n* frequency with druggable targets with available on-label therapy option\n* treatment decisions in the presence of more than one druggable target'}, {'measure': 'Outcome of treatment', 'timeFrame': '3 years', 'description': 'To describe outcome of treatment in patients receiving therapy in concordance with the test result'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer of Unknown Origin', 'Cancer Refractory', 'Cancer of Stomach', 'Cancer Head Neck', 'Cancer of Skin', 'Cancer, Lung', 'Cancer Colorectal', 'Cancer of Esophagus', 'Cancer, Bladder', 'Cancer, Uterus', 'Cancer Cervix', 'Cancer Liver', 'Cancer, Kidney', 'Cancer, Breast', 'Hematologic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '34371380', 'type': 'DERIVED', 'citation': 'Heregger R, Huemer F, Hutarew G, Hecht S, Cheveresan L, Kotzot D, Schamschula E, Rinnerthaler G, Melchardt T, Weiss L, Greil R. Sustained response to brigatinib in a patient with refractory metastatic pheochromocytoma harboring R1192P anaplastic lymphoma kinase mutation: a case report from the Austrian Group Medical Tumor Therapy next-generation sequencing registry and discussion of the literature. ESMO Open. 2021 Aug;6(4):100233. doi: 10.1016/j.esmoop.2021.100233. Epub 2021 Aug 7.'}]}, 'descriptionModule': {'briefSummary': 'There is no evidence available about which molecular profiling methods are currently used for cancer patients in Austrian clinical practice. The construction of the registry proposed as a completely independent research endeavor, will be helpful for scientific evaluation and the establishment of highly credible data.', 'detailedDescription': 'In the situation of enormous possible beneficial options for patients, health care systems, researchers and companies and the simultaneously present high number of uncertainties, the establishment of an independent registry for patients undergoing any type of comprehensive genomic profiling offers many advantages.\n\nIn particular, an overview of the speed of development, the "market penetration", the use of the technology in specific indications (tumor types, stages and in specific situations of unresponsiveness to certain drugs), the frequency by which treatment decisions will definitely follow the result of comprehensive genomic profiling and the reasons for this, the treatment outcome of such patients, the platform technologies applied (in-house (which types), vs. commercial) and the development of these parameters over time and in relation to the development of novel drugs will be analyzed.\n\nThe registry proposes to cover the time period from the years 2016 to 2019, which will allow for assessment of both the current and emerging landscape of genomic/molecular testing practice in Austria and effect of molecular profiling on patient care and outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of oncology patients who received or plan to receive comprehensive genomic testing anytime on or after January 1, 2016. Patient medical, testing and treatment information will be obtained through extraction of data from existing patient medical charts. Longitudinal follow-up data, including survival and tumor progression, will also be extracted from patient medical charts. This patient follow-up data will be obtained until patient death or loss to follow-up.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThis registry will include cancer patients for which broad genomic profiling is indicated as assessed by the medical need and as deemed appropriate by the physician, for example\n\n* cancer with high mutational load and suspicion of regular or frequent formation of neoantigens\n\n * skin, lung, stomach, esophagus, colorectum, bladder, uterus, cervix, liver, head and neck, kidney, breast\n * lymphoma B-cell\n* any other neoplastic disease where molecular targeting is performed but treatment fails\n* cancer of unknown primary origin (CUP)\n* planned or already carried out comprehensive genomic testing as of Jan 1, 2016 note: this registry will not initially register patients who are tested for only 1-5 mutations by conventional means, but patients undergoing genomic profiling based on NGS)\n* a patient´s signed informed consent\n* Patients ≥ 18 years of age\n\nExclusion Criteria:\n\n* Due to the non-interventional design of the registry there are no specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT03301493', 'briefTitle': 'Genomic Testing and Resulting Medical Decisions', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'The Use of Genomic Testing and the Resulting Medical Decisions According to Target Identification', 'orgStudyIdInfo': {'id': 'AGMT_NGS-Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Genomic testing', 'type': 'OTHER', 'description': 'Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'IIIrd Medical Department, Private Medical University Hospital Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '6807', 'city': 'Feldkirch', 'country': 'Austria', 'facility': 'Innere Medizin II, LKH Feldkirch', 'geoPoint': {'lat': 47.23306, 'lon': 9.6}}, {'zip': 'A-8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz, Univ.-Klinik f. Innere Medizin, Onkologie', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6500', 'city': 'Krems', 'country': 'Austria', 'facility': 'Universitätsklinikum Krems', 'geoPoint': {'lat': 48.40921, 'lon': 15.61415}}, {'zip': 'A-4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'BHS Linz: Interne I: Internistische Onkologie, Hämatologie und Gastroenterologie', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '3100', 'city': 'Sankt Pölten', 'country': 'Austria', 'facility': 'Universitätsklinikum St. Pölten', 'geoPoint': {'lat': 48.20762, 'lon': 15.63725}}, {'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medizinische Universität Wien', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '4840', 'city': 'Vöcklabruck', 'country': 'Austria', 'facility': 'Salzkammergut-Klinikum Vöcklabruck', 'geoPoint': {'lat': 48.00279, 'lon': 13.65652}}, {'zip': '4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Klinikum Wels-Grieskirchen GmbH', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': '6511', 'city': 'Zams', 'country': 'Austria', 'facility': 'St. Vinzenz Krankenhaus Betriebs GmbH', 'geoPoint': {'lat': 47.15844, 'lon': 10.5897}}], 'overallOfficials': [{'name': 'Richard Greil, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IIIrd Medical Department, Private Medical University Hospital Salzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}, {'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}