Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-04 @ 12:20 PM
Study NCT ID:
NCT04158661
Status:
UNKNOWN
Last Update Posted:
2021-09-24
First Post:
2019-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013934', 'term': 'Thymectomy'}], 'ancestors': [{'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-23', 'studyFirstSubmitDate': '2019-11-07', 'studyFirstSubmitQcDate': '2019-11-07', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean daily prednisone dose', 'timeFrame': 'three years after thymectomy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'Robotic-assisted minimally-invasive thymectomy', 'Mean daily prednisone dose'], 'conditions': ['Myasthenia Gravis']}, 'referencesModule': {'references': [{'pmid': '27509100', 'type': 'BACKGROUND', 'citation': 'Wolfe GI, Kaminski HJ, Aban IB, Minisman G, Kuo HC, Marx A, Strobel P, Mazia C, Oger J, Cea JG, Heckmann JM, Evoli A, Nix W, Ciafaloni E, Antonini G, Witoonpanich R, King JO, Beydoun SR, Chalk CH, Barboi AC, Amato AA, Shaibani AI, Katirji B, Lecky BR, Buckley C, Vincent A, Dias-Tosta E, Yoshikawa H, Waddington-Cruz M, Pulley MT, Rivner MH, Kostera-Pruszczyk A, Pascuzzi RM, Jackson CE, Garcia Ramos GS, Verschuuren JJ, Massey JM, Kissel JT, Werneck LC, Benatar M, Barohn RJ, Tandan R, Mozaffar T, Conwit R, Odenkirchen J, Sonett JR, Jaretzki A 3rd, Newsom-Davis J, Cutter GR; MGTX Study Group. Randomized Trial of Thymectomy in Myasthenia Gravis. N Engl J Med. 2016 Aug 11;375(6):511-22. doi: 10.1056/NEJMoa1602489.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. The planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data).\n\nPrimary hypothesis: Minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).', 'detailedDescription': 'Based on large cohort studies of the last decades, the thymectomy has become a central component of the immunomodulating therapy in MG patients without thymoma detection. Because randomized studies were missing, remained a residual uncertainty on the importance of Thymectomy. In the study "Randomized Trial of Thymectomy in Myasthenia Gravis" (MGTX-study) published 2016 the effectiveness of thymectomy by patients without thymoma detection has been indisputable confirmed. A significant improvement of the patient\'s complaints and the reduction of the immunosuppressive drugs were particularly evident by early onset MG (EOMG) two to three years after performing a complete resection of the thymic tissue.\n\nWhile the MGTX study (with an open operative procedure) was being done, the minimally-invasive thymectomy has gained more and more acceptance. From a surgical point of view, the minimally invasive thoracoscopic procedure represents a gentler alternative. According to the momentaneous clinical-scientific point of view, further studies are necessary to compare both procedures. Furthermore, the MGTX study included only patients with generalized MG and positive anti-Acetylcholine Receptor (AChR)-antibodies, who were younger than 65 years, so that the relevance of thymectomy in other important subgroups, such as late onset MG (LOMG), the ocular MG (OMG), as well as the patients without detected antibodies (seronegative MG patients), who represent about 10 % of whole population of MG patients, is still not clear.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with confirmed diagnosis of myasthenia gravis by:\n\n* typical clinical features AND\n* antibody diagnostic AND\n* positive edrophonium test OR\n* abnormal repetitive nerve stimulation OR\n* abnormal single-fiber electromyography.\n\nMyasthenia Gravis Foundation of America clinical classification (MGFA classification) of I to V was accepted (class I indicates weakness only in ocular muscles, class II mild generalized disease, class III moderate generalized disease, class IV severe generalized disease and class V a crisis requiring Intubation)\n\nParticipants could be taking appropriate anticholinesterase therapy with or without oral glucocorticoids', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with Myasthenia Gravis\n* Age ≥18 years\n\nExclusion Criteria:\n\n* a proper communication with the patient is not possible\n* an informed consent could not be signed\n* a patient reject a participation or requires breaking up'}, 'identificationModule': {'nctId': 'NCT04158661', 'briefTitle': 'Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Influence of Minimally Invasive Thymectomy on the Subsequent Clinical Course of Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'Mya-Thymektomie'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tmin-group', 'description': '* confirmed seropositive ocular or generalized MG \\[detection of antibodies (Abs) targeting the AChR, muscle-specific tyrosine kinase (MuSK) or Titin\\] or seronegative ocular or generalized MG\n* age ≥ 18 years\n* thymectomy ≥ three years', 'interventionNames': ['Procedure: thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)']}, {'label': 'T0-group', 'description': '* confirmed seropositive ocular or generalized MG \\[detection of antibodies (Abs) targeting the AChR, muscle-specific tyrosine kinase (MuSK) or Titin\\] or seronegative ocular or generalized MG\n* a very long disease history OR\n* age ≥ 18 years\n* rejecting a thymectomy or have contraindications for thymectomy', 'interventionNames': ['Procedure: no thymectomy (control)']}, {'label': 'MGTX-group ("historical control group")', 'description': 'from MGTX-trial ("Randomized Trial of Thymectomy in Myasthenia Gravis")', 'interventionNames': ['Procedure: thymectomy by means of median sternotomy (transsternal)']}], 'interventions': [{'name': 'thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)', 'type': 'PROCEDURE', 'description': 'preferring one unilateral access and placing three trocars between 3rd and 5th intercostal space in a triangular configuration, with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).', 'armGroupLabels': ['Tmin-group']}, {'name': 'thymectomy by means of median sternotomy (transsternal)', 'type': 'PROCEDURE', 'description': 'with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).', 'armGroupLabels': ['MGTX-group ("historical control group")']}, {'name': 'no thymectomy (control)', 'type': 'PROCEDURE', 'description': 'routine medical care', 'armGroupLabels': ['T0-group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Sana Klinikum Lichtenberg', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Mitte', 'country': 'Germany', 'facility': 'Department of Surgery Charité University', 'geoPoint': {'lat': 52.52003, 'lon': 13.40489}}, {'city': 'Mitte', 'country': 'Germany', 'facility': 'NeuroCure Clinical Research Center (NCRC), Charité University, Berlin', 'geoPoint': {'lat': 52.52003, 'lon': 13.40489}}], 'overallOfficials': [{'name': 'Andreas Meisel, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}, {'name': 'Department of Surgery, Charite, Berlin', 'class': 'UNKNOWN'}, {'name': 'Sana Klinikum Lichtenberg, Berlin', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}