Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-27 @ 9:32 PM
Study NCT ID:
NCT06201650
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofilament Light Chain in Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'C537987', 'term': 'Charcot-Marie-Tooth disease, Type 1F'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-31', 'studyFirstSubmitDate': '2023-04-01', 'studyFirstSubmitQcDate': '2023-12-31', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation of serum neurofilament light chain to ALS progression', 'timeFrame': '2020-2024', 'description': 'correlation of serum neurofilament light chain (NfL) with the ALS progression rate as measured by the revised form of the ALS function rating scale (ALSFRS-R)'}, {'measure': 'correlation of serum neurofilament light chain with ALS phenotypes', 'timeFrame': '2020-2024', 'description': 'correlation of serum neurofilament light chain with ALS phenotypes in terms of type of onset and clinical variants including progressive muscle atrophy, primary lateral sclerosis, flail-arm syndrome, flail-leg syndrome and other phenotypes'}, {'measure': 'correlation of serum neurofilament light chain with ALS treatment options', 'timeFrame': '2020-2024', 'description': 'correlation of serum neurofilament light chain to ALS interventions such as treatment with tofersen and other medicines'}], 'secondaryOutcomes': [{'measure': 'correlation of serum neurofilament light chain with non-pharmacologic ALS interventions', 'timeFrame': '2022-2024', 'description': 'correlation of serum neurofilament light chain with non-pharmacologic ALS interventions including nutrition or ventilation treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ALS', 'Amyotrophic lateral sclerosis', 'Neurofilament light chain', 'NfL', 'ALS Funktional Rating Scale', 'Progression', 'biomarker', 'treatment marker', 'therapeutic marker'], 'conditions': ['Amyotrophic Lateral Sclerosis', 'Motor Neuron Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://als-charite.de/', 'label': 'Website of principle investigator'}, {'url': 'https://canessa-als-stiftung.org/', 'label': 'Website of funding organization'}]}, 'descriptionModule': {'briefSummary': 'This study assesses the performance of serum neurofilament light chain (sNfL) in amyotrophic lateral sclerosis (ALS) in a wide range of disease courses, in terms of ALS progression, disease duration, and tracheostomy invasive ventilation (TIV). The aim of the research project is to investigate the correlation between NfL serum concentration and the natural course of the disease, the ALS progression rate, and specific phenotypes of ALS. Furthermore, the performance of NfL as a therapeutic biomarker will be studied. A systematic analysis of the NfL serum concentration in a cohort of 3,000 ALS patients using the Single Molecule Analysis method (SIMOA) will be performed. This analysis is carried out as a multi-center study.', 'detailedDescription': 'The aim of this study is to investigate the correlation between the NfL serum concentration and the natural course of the disease, the ALS progression rate as measured by the ALS functional rating scale (ALSFRS-R), and specific phenotypes of ALS. The results of the study will contribute to the assessment of disease progression and the prognosis making of ALS. Furthermore, the performance of NfL as a therapeutic marker of ALS medicines and non-pharmacologic treatment options will be investigated. A systematic analysis of the NfL serum concentration in an extended cohort of ALS patients using the Single Molecule Analysis method (SIMOA) will be performed.\n\nResearch objectives comprise:\n\n* Correlation of NfL with disease progression, including duration of ALS disease\n* Correlation of NfL with the course of ALS (classic ALS or variants in the motor neuron involvement or the regional propagation patterns)\n* Correlation of NfL with the progression rate of ALS\n\nCohorts on phenotypic variants:\n\nThe clinical phenotype of ALS will be differentiated according to the motor neuron involvement or regional propagation patterns of disease onset and clinical course.\n\nALS variants in relation to motor neuron involvement:\n\n* Typical ALS: clinical features for an affection of the 1st and 2nd motor neurons are present\n* Progressive muscular atrophy (PMA): only clinical features for an affection of the 2nd motor neuron are present\n* Spastic ALS: predominantly clinical features for an affection of the 1st motor neuron and fewer signs of an affection of the 2nd motor neuron\n* Primary lateral sclerosis (PLS): only clinical features for an affection of the 1st motor neuron are present\n\nALS variants in regional propagation patterns:\n\n* Typical form: paresis of the upper or lower extremities or the bulbar region as well as the spread of the paresis to other regions\n* Flail arm syndrome: primary and dominant paresis of the upper extremities and little or delayed spread of the paresis to other regions\n* Flail leg syndrome: primary and dominant paresis of the lower extremities and little or delayed spread of the paresis to other regions\n* Axial ALS: primary and dominant paresis of the trunk muscles and minor or delayed spread of the paresis to other regions\n* Progressive bulbar paralysis: primary and dominant paresis in the bulbar region and slight or delayed spread of the paresis to other regions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with clinical diagnosis of amyotrophic lateral sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of amyotrophic lateral sclerosis including specific forms\n* Patient's informed consent to participate in this study\n* Minimum age of 18 years\n* Willingness for blood collection\n\nExclusion Criteria:\n\n* Unwillingness to store and share pseudonymized medical data collected in the study\n* Evaluation by the investigator, which excludes participation"}, 'identificationModule': {'nctId': 'NCT06201650', 'acronym': 'NfL-ALS', 'briefTitle': 'Neurofilament Light Chain in Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Performance of Serum Neurofilament Light Chain in a Wide Spectrum of Clinical Courses of Amyotrophic Lateral Sclerosis - a Cross-sectional and Longitudinal Multicenter Study', 'orgStudyIdInfo': {'id': 'NfL-ALS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Neurofilament light chain', 'type': 'DIAGNOSTIC_TEST', 'description': 'Neurofilament light chain as biomarker for amyotrophic lateral sclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'NOT_YET_RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Wolfgang Löscher, Prof Dr', 'role': 'CONTACT'}, {'name': 'Wolfgang Löscher, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medizinische Universität Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '12621', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Richter, Dr', 'role': 'CONTACT'}, {'name': 'Christoph Richter, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vivantes Klinikum Kaulsdorf', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Meyer, Prof Dr', 'role': 'CONTACT', 'email': 'thomas.meyer@charite.de'}, {'name': 'Erma Salkic', 'role': 'CONTACT', 'email': 'erma.salkic@charite.de'}, {'name': 'Thomas Meyer, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44789', 'city': 'Bochum', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ute Weyen, Dr', 'role': 'CONTACT'}, {'name': 'Ute Weyen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '53127', 'city': 'Bonn', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Patrick Weydt, PD Dr', 'role': 'CONTACT'}, {'name': 'Patrick Weydt, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '01062', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'René Günther, Dr', 'role': 'CONTACT'}, {'name': 'René Günther, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Technische Universität Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '45131', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Torsten Grehl, Dr', 'role': 'CONTACT'}, {'name': 'Torsten Grehl, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alfried Krupp von Bohlen und Halbach Krankenhaus gGmbH', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45147', 'city': 'Essen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Tim Hagenacker, Prof Dr', 'role': 'CONTACT'}, {'name': 'Tim Hagenacker, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '37075', 'city': 'Göttingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan Koch, PD Dr', 'role': 'CONTACT'}, {'name': 'Jan Koch, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georg-August-Universität Göttingen Universitätsmedizin Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30625', 'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Petri, Prof Dr', 'role': 'CONTACT'}, {'name': 'Susanne Petri, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Medizinische Hochschule Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': '07743', 'city': 'Jena', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Robert Steinbach, Dr', 'role': 'CONTACT'}], 'facility': 'Universitätsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '04103', 'city': 'Leipzig', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Petra Baum, PD Dr', 'role': 'CONTACT'}, {'name': 'Petra Baum, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universität Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '23538', 'city': 'Lübeck', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Julian Grosskreutz, Prof Dr', 'role': 'CONTACT'}, {'name': 'Julian Grosskreutz, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '68167', 'city': 'Mannheim', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jochen Weishaupt, Prof Dr', 'role': 'CONTACT'}, {'name': 'Jochen Weishaupt, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universität Heidelberg Medizinische Fakultät Mannheim', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '81675', 'city': 'München', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Paul Lingor, Prof Dr', 'role': 'CONTACT'}, {'name': 'Paul Lingor, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinikum rechts der Isar der Technischen Universität München', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Matthias Boentert, PD DR', 'role': 'CONTACT'}, {'name': 'Matthias Boentert, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Westfälische Wilhelms-Universität Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '93053', 'city': 'Regensburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Zacharias Kohl, PD Dr', 'role': 'CONTACT'}, {'name': 'Zacharias Kohl, PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '18057', 'city': 'Rostock', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Hermann, Prof. Dr. med. Dr. rer. med.', 'role': 'CONTACT'}, {'name': 'Andreas Hermann, Prof Dr Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsmedizin Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': '89081', 'city': 'Ulm', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Johannes Dorst, Prof Dr', 'role': 'CONTACT'}, {'name': 'Johannes Dorst, Prof Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'centralContacts': [{'name': 'Thomas Meyer, MD', 'role': 'CONTACT', 'email': 'thomas.meyer@charite.de', 'phone': '004930450560028'}, {'name': 'Péter Körtvélyessy, MD', 'role': 'CONTACT', 'email': 'peter.koertvelyessy@charite.de', 'phone': '004930450560028'}], 'overallOfficials': [{'name': 'Thomas Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boris Canessa ALS Stiftung', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Thomas Meyer', 'investigatorFullName': 'Thomas Meyer, MD', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}