Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT05554835
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2022-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Global Registry and Natural History Study for Mitochondrial Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D028361', 'term': 'Mitochondrial Diseases'}, {'id': 'D007625', 'term': 'Kearns-Sayre Syndrome'}, {'id': 'C579922', 'term': 'Ataxia Neuropathy Spectrum'}, {'id': 'C537396', 'term': 'Neuropathy ataxia and retinitis pigmentosa'}, {'id': 'D017241', 'term': 'MELAS Syndrome'}, {'id': 'D017243', 'term': 'MERRF Syndrome'}, {'id': 'C564403', 'term': 'Coenzyme Q10 Deficiency'}, {'id': 'D056889', 'term': 'Barth Syndrome'}, {'id': 'D017240', 'term': 'Mitochondrial Myopathies'}, {'id': 'D007888', 'term': 'Leigh Disease'}, {'id': 'C536353', 'term': 'VLCAD deficiency'}, {'id': 'D017246', 'term': 'Ophthalmoplegia, Chronic Progressive External'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012174', 'term': 'Retinitis Pigmentosa'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D017237', 'term': 'Mitochondrial Encephalomyopathies'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020191', 'term': 'Myoclonic Epilepsies, Progressive'}, {'id': 'D004831', 'term': 'Epilepsies, Myoclonic'}, {'id': 'D004829', 'term': 'Epilepsy, Generalized'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D015323', 'term': 'Pyruvate Metabolism, Inborn Errors'}, {'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2022-08-11', 'studyFirstSubmitQcDate': '2022-09-23', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Newcastle Mitochondrial Disease Scale for Adults (NMDAS), Sections I-III', 'timeFrame': 'The individual participants are followed with annual assessments over a long time period (up to 30 years) or until discontinuation or death.', 'description': 'Newcastle Mitochondrial Disease Scale for Adults (NMDAS) is a clinical rating scale designed for mitochondrial disease. The rating scale explores several domains: current function, system specific involvement and current clinical assessment. The individual scores are summed to provide a total score that ranges from 0 to 145; higher scores indicate more severely affection.'}, {'measure': 'Newcastle Pediatric Mitochondrial Disease Scale for Children (NPMDS)', 'timeFrame': 'The individual participants are followed with annual assessments until they reach the next age group version (up to 18 years) or until discontinuation or death.', 'description': 'NPMDS is a clinical rating scale designed for mitochondrial disease in children.\n\nThere are three versions of the NPMDS, each for a specific age range (0-24 months, 2-11 years, and 12-18 years). The rating scale explores several domains: current function (Section I), system specific involvement (Section II), current clinical assessment (Section III) and quality of life (QoL) assessments (Section IV). The individual scores in Section I-III are summed to provide a total score that ranges from 0 to 70 (version 0-24month) and 0-82 (versions 2-18 years); higher scores indicate more severely affection. Section IV (QoL) is scored separately and provide a total score that ranges from 0 to 25 with higher scores indicating better quality of life.'}, {'measure': 'Scale for the assessment and rating of ataxia (SARA) in adults', 'timeFrame': 'The individual participants are followed with annual assessments over a long time period (up to 30 years) or until discontinuation or death.', 'description': 'The Scale for the Assessment and Rating of Ataxia (SARA) is a clinical scale used to assess cerebellar ataxia in adults. The scale includes 8 items, related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test. The individual scores are summed to provide a total score that ranges from 0 to 40, higher scores indicate more severe ataxia.'}, {'measure': 'Disease progression', 'timeFrame': 'The individual participants are followed with annual assessments over a long time period (up to 30 years) or until discontinuation or death.', 'description': 'Disease progression as assessed by clinical examination and captured as HPO (Human Phenotype Ontology) Terms at each visit.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Registry'], 'conditions': ['Mitochondrial Diseases', 'Kearns-Sayre Syndrome', 'MIDD', 'SANDO', 'SCAE', 'NARP Syndrome', 'MELAS Syndrome', 'MERRF Syndrome', 'Coenzyme Q10 Deficiency', 'LHON', 'MNGIE', 'MIRAS', 'Barth Syndrome', 'MDS', 'Mitochondrial Myopathies', 'Leigh Syndrome', 'Pearson Syndrome', 'CPEO']}, 'referencesModule': {'references': [{'pmid': '33465056', 'type': 'BACKGROUND', 'citation': "Stenton SL, Sheremet NL, Catarino CB, Andreeva NA, Assouline Z, Barboni P, Barel O, Berutti R, Bychkov I, Caporali L, Capristo M, Carbonelli M, Cascavilla ML, Charbel Issa P, Freisinger P, Gerber S, Ghezzi D, Graf E, Heidler J, Hempel M, Heon E, Itkis YS, Javasky E, Kaplan J, Kopajtich R, Kornblum C, Kovacs-Nagy R, Krylova TD, Kunz WS, La Morgia C, Lamperti C, Ludwig C, Malacarne PF, Maresca A, Mayr JA, Meisterknecht J, Nevinitsyna TA, Palombo F, Pode-Shakked B, Shmelkova MS, Strom TM, Tagliavini F, Tzadok M, van der Ven AT, Vignal-Clermont C, Wagner M, Zakharova EY, Zhorzholadze NV, Rozet JM, Carelli V, Tsygankova PG, Klopstock T, Wittig I, Prokisch H. Impaired complex I repair causes recessive Leber's hereditary optic neuropathy. J Clin Invest. 2021 Mar 15;131(6):e138267. doi: 10.1172/JCI138267."}, {'pmid': '32042921', 'type': 'BACKGROUND', 'citation': 'Stendel C, Neuhofer C, Floride E, Yuqing S, Ganetzky RD, Park J, Freisinger P, Kornblum C, Kleinle S, Schols L, Distelmaier F, Stettner GM, Buchner B, Falk MJ, Mayr JA, Synofzik M, Abicht A, Haack TB, Prokisch H, Wortmann SB, Murayama K, Fang F, Klopstock T; ATP6 Study Group. Delineating MT-ATP6-associated disease: From isolated neuropathy to early onset neurodegeneration. Neurol Genet. 2020 Jan 13;6(1):e393. doi: 10.1212/NXG.0000000000000393. eCollection 2020 Feb.'}, {'pmid': '34146515', 'type': 'BACKGROUND', 'citation': 'Ng YS, Bindoff LA, Gorman GS, Klopstock T, Kornblum C, Mancuso M, McFarland R, Sue CM, Suomalainen A, Taylor RW, Thorburn DR, Turnbull DM. Mitochondrial disease in adults: recent advances and future promise. Lancet Neurol. 2021 Jul;20(7):573-584. doi: 10.1016/S1474-4422(21)00098-3.'}, {'pmid': '32090171', 'type': 'BACKGROUND', 'citation': 'Ng YS, Bindoff LA, Gorman GS, Horvath R, Klopstock T, Mancuso M, Martikainen MH, Mcfarland R, Nesbitt V, Pitceathly RDS, Schaefer AM, Turnbull DM. Consensus-based statements for the management of mitochondrial stroke-like episodes. Wellcome Open Res. 2019 Dec 13;4:201. doi: 10.12688/wellcomeopenres.15599.1. eCollection 2019.'}, {'pmid': '29074296', 'type': 'BACKGROUND', 'citation': 'Mancuso M, McFarland R, Klopstock T, Hirano M; consortium on Trial Readiness in Mitochondrial Myopathies. International Workshop:: Outcome measures and clinical trial readiness in primary mitochondrial myopathies in children and adults. Consensus recommendations. 16-18 November 2016, Rome, Italy. Neuromuscul Disord. 2017 Dec;27(12):1126-1137. doi: 10.1016/j.nmd.2017.08.006. Epub 2017 Sep 8. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://genomit.eu/work-packages/global-registry-and-trial-readiness/index.html', 'label': 'Project website'}, {'url': 'https://www.mitonet.org/netzwerk/patientenregister_biobank/', 'label': 'mitoNET website'}, {'url': 'https://www.mitocon.it/', 'label': 'Mitocon website'}]}, 'descriptionModule': {'briefSummary': 'The main goal of the project is provision of a global registry for mitochondrial disorders to harmonize previous national registries, enable world-wide participation and facilitate natural history studies, definition of outcome measures and conduction of clinical trials.', 'detailedDescription': 'The global mitochondrial registry and natural history study is part of the EU-financed GENOMIT project, co-ordinated by Dr. Holger Prokisch, Technische Universität München (TUM).It aims at advancing the understanding of the natural history of mitochondrial disease to inform the design and facilitate the conduction of clinical trials. It also serves as a catalyst for translating basic research results into clinical practice.\n\nThe global mitochondrial registry and natural history study provides for all contingencies of national ethics and data protection rules including data access management.\n\nCurrently participating networks are:\n\n* German network for mitochondrial diseases - mitoNET, Germany/Austria\n* Italian Registry of Mitochondrial Patients - Mitocon, Italy\n\nThe inclusion of other networks and countries is possible and explicitly welcome. A major advantage of the global registry is that countries can join in, saving a lot of time, effort and funding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* suspected or confirmed mitochondrial disease\n* willingness to participate\n\nExclusion Criteria:\n\n* unwillingness to participate'}, 'identificationModule': {'nctId': 'NCT05554835', 'acronym': 'GENOMIT', 'briefTitle': 'Global Registry and Natural History Study for Mitochondrial Disorders', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Global Mitochondrial Registry to Define Natural History and Outcome Measures to Achieve Definite Trial Readiness for Mitochondrial Disorders', 'orgStudyIdInfo': {'id': 'mitoGLOBAL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mitochondrial patients', 'description': 'Patients with a suspected or confirmed mitochondrial disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Daniela Karall, Prof. Dr.', 'role': 'CONTACT', 'email': 'daniela.karall@i-med.ac.at', 'phone': '+43 512 504', 'phoneExt': '23600'}], 'facility': 'Medical University Innsbruck, Department of Pediatrics', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '5020', 'city': 'Salzburg', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Saskia Wortmann, PD Dr. med.', 'role': 'CONTACT', 'phone': '+43 5 7255', 'phoneExt': '26222'}, {'name': 'Elisa Floride, Dr.', 'role': 'CONTACT', 'email': 'e.floride@salk.at', 'phone': '+43 5 7255', 'phoneExt': '26222'}], 'facility': 'Salzburger Landeskliniken, SALK, Paracelsus Medizinische Privatuniversität', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '81675', 'city': 'Munich', 'state': 'Bavaria', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Marcus Deschauer, Prof. Dr.', 'role': 'CONTACT', 'phone': '+49 89 4140', 'phoneExt': '4617'}, {'name': 'Luisa Semmler', 'role': 'CONTACT'}], 'facility': 'Department of neurology, Klinikum rechts der Isar, Technical University Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Schülke-Gerstenfeld, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'Markus.Schuelke@charite.de', 'phone': '+49 30 4505 66112'}], 'facility': 'Charité Virchow Klinikum, Klinik für Pädiatrie m. S. Neurologie', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Cornelia Kornblum, Prof. Dr.', 'role': 'CONTACT', 'email': 'Cornelia.Kornblum@ukbonn.de', 'phone': '+49 228 287 15712'}], 'facility': 'Universität Bonn, Klinik und Poliklinik für Neurologie', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '50931', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jürgen-Christoph von Kleist-Retzow, PD Dr.', 'role': 'CONTACT', 'email': 'juergen-christoph.vonkleist@uk-koeln.de', 'phone': '+49 221 478 5900'}], 'facility': 'Universitätsklinikum Köln, Klinik und Poliklinik für Kinder- und Jugendmedizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '40225', 'city': 'Düsseldorf', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Felix Distelmaier, Prof. Dr.', 'role': 'CONTACT', 'email': 'Felix.Distelmaier@med.uni-duesseldorf.de', 'phone': '+49 211 811 7696'}], 'facility': 'Universitätsklinikum Düsseldorf, Klinik für allgemeine Pädiatrie, Neonatologie und Kinderkardiologie', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Kieslich, Prof.Dr.med.', 'role': 'CONTACT', 'phone': '+49 69 6301 5560'}, {'name': 'Martin Lindner, PD Dr. med.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Frankfurt, Klinik für Kinder- und Jugendmedizin, Schwerpunkt Neurologie, Neurometabolik und Prävention', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Eckenweiler, Dr.', 'role': 'CONTACT', 'email': 'matthias.eckenweiler@uniklinik-freiburg.de', 'phone': '+49 761 270', 'phoneExt': '43750'}, {'name': 'Simone Bürklin', 'role': 'CONTACT', 'email': 'simone.buerklin@uniklinik-freiburg.de', 'phone': '+49 761 270', 'phoneExt': '44970'}], 'facility': 'University Medical Center Freiburg, Center for children and youth medicine', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '06097', 'city': 'Halle', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Alexander Mensch, Dr. med.', 'role': 'CONTACT', 'phone': '49 345 557 2856'}, {'name': 'Annamarie Thäle, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Martin-Luther-Universität Halle-Wittenberg, Neurologische Klinik und Poliklinik', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maja Hempel, PD Dr. med.', 'role': 'CONTACT', 'email': 'm.hempel@uke.de', 'phone': '+49 40 7410 50772'}], 'facility': 'Universitätsklinikum Hamburg Eppendorf Institut für Humangenetik', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'René Santer, Prof.Dr.med.', 'role': 'CONTACT', 'phone': '+49 40 7410 52710'}, {'name': 'Konstantinos Tsiakas, Dr. med.', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Hamburg Eppendorf, Klinik für Kinder-und Jugendmedizin', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '20246', 'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Simone Zittel-Dirks, PD Dr. med.', 'role': 'CONTACT', 'email': 's.zittel-dirks@uke.de'}], 'facility': 'Universitätsklinikum Hamburg Eppendorf, Klinik für Neurologie', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Georg F. Hoffmann, Prof. Dr.', 'role': 'CONTACT', 'phone': '+49 6221 56 4837'}, {'name': 'Nikolas Boy, PD Dr. med.', 'role': 'CONTACT', 'email': 'nikolas.boy@med.uni-heidelberg.de', 'phone': '+49 6221 56 4002'}], 'facility': 'Universitätsklinikum Heidelberg, Zentrum für Kinder- und Jugendmedizin, Sektion für Neuropädiatrie und Stoffwechselmedizin', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '80336', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Klopstock, Prof. Dr.', 'role': 'CONTACT', 'phone': '+49 89 4400 57400'}, {'name': 'Boriana Büchner, Dr. med.', 'role': 'CONTACT', 'email': 'boriana.buechner@med.uni-muenchen.de', 'phone': '+49 89 4400 57067'}], 'facility': 'LMU Klinikum, Friedrich-Baur-Institut an der Neurologischen Klinik und Poliklinik', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '72764', 'city': 'Reutlingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peter Freisinger, Prof. Dr.', 'role': 'CONTACT', 'email': 'freisinger_p@klin-rt.de', 'phone': '+49 7121 200 4051'}, {'name': 'Vanessa Kock, Dr. med.', 'role': 'CONTACT', 'phone': '+49 7121 200 4060'}], 'facility': 'Klinikum am Steinenberg, Kreiskliniken Reutlingen, Klinik für Kinder-und Jugendmedizin, Perinatal- u. Stoffwechselzentrum', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ludger Schöls, Prof. Dr.', 'role': 'CONTACT', 'email': 'ludger.schoels@uni-tuebingen.de', 'phone': '+49 7071 29 82057'}], 'facility': 'Universitätsklinikum Tübingen, Neurologische Klinik und Hertie Institut für Klinische Hirnforschung', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Michaelangelo Mancuso, Prof. Dr.', 'role': 'CONTACT', 'email': 'michelangelo.mancuso@unipi.it', 'phone': '+39 (0)50 992443'}], 'facility': 'Department of Clinical and Experimental Medicine, Neurological Institute, University of Pisa & AOUP', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'centralContacts': [{'name': 'Boriana Büchner, Dr.', 'role': 'CONTACT', 'email': 'boriana.buechner@med.uni-muenchen.de', 'phone': '+49 89 4400', 'phoneExt': '57067'}], 'overallOfficials': [{'name': 'Thomas Klopstock, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMU Klinikum, Munich'}, {'name': 'Michelangelo Mancuso, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università di Pisa'}]}, 'ipdSharingStatementModule': {'url': 'https://www.mitonet.org/netzwerk/patientenregister_biobank/beantragung-von-daten-proben/', 'infoTypes': ['ICF'], 'timeFrame': 'Time frame for data usage needs to be specified in the proposal for data sharing.', 'ipdSharing': 'YES', 'description': 'Any data or results from the project can be shared upon written request with researchers. Data sharing requires approval by the respective scientific committee and their institutional review board.', 'accessCriteria': 'Approved written proposal including the description of the research plan and data usage purpose.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Commission', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}, {'name': 'University of Pisa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Thomas Klopstock', 'investigatorFullName': 'Prof. Thomas Klopstock', 'investigatorAffiliation': 'LMU Klinikum'}}}}