[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100449836":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":21,"locations":30,"responsibleParty":259,"collaborators":10,"id":261,"slug":262,"hasResults":263,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":269,"sex":270,"minAge":271,"maxAge":10,"enrollmentInfo":272,"targetDuration":275,"studyType":276,"phases":10,"briefSummary":277,"conditions":278,"keywords":283,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},{"fullName":5,"class":6},"Target ALS Foundation, Inc.","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Amyotrophic Lateral Sclerosis ALS",null,"This is a global, multi-center study of ALS participants and healthy controls that will have up to 20 sites globally. Target enrollment will be approximately 1000 participants with 800 ALS participants and 200 healthy control cases. Research participants with suspected, possible, probable, probable- laboratory supported, and definite Amyotrophic Lateral Sclerosis (ALS), according to the revised El Escorial Criteria (EEC) or with a diagnosis based on the Gold Coast Criteria will be seen at the Screening\u002FBaseline Visit(s) (Visit 1) and follow-up will occur at approximate 4-month internals for up to 5 visits per participant.",{"label":13,"type":10,"description":14,"interventionNames":10},"Healthy","Healthy control participants will have a neurological exam to confirm non-neurologic disease status and participants will have one follow up visit approximately 12 months after their baseline visit. Upon consenting for participation, all study participants will undergo the activities and biofluid collections at each visit.",[16,19],{"name":17,"affiliation":5,"role":18},"Laura Dugom, MPH","STUDY_DIRECTOR",{"name":20,"affiliation":5,"role":18},"Amy Easton, PhD",[22,26],{"name":17,"role":23,"phone":24,"phoneExt":10,"email":25},"CONTACT","919-440-2073","laura.dugom@targetals.org",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Robert Bowser, PhD","602-406-8989","robert.bowser@dignityhealth.org",[31,54,70,88,104,124,145,163,183,205,221,240],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Barrow Neurological Institute","RECRUITING","Phoenix","Arizona","85013","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-112.07404,33.44838,{"lat":43,"lon":42},[46,51],{"name":47,"role":23,"phone":48,"phoneExt":49,"email":50},"Whitney Dailey, 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Moreno","l.acevedo@ioir.org.co",{"name":239,"role":53,"phone":10,"phoneExt":10,"email":10},"Martha Pena, MD",{"facility":241,"status":33,"city":242,"state":10,"zip":243,"country":244,"countryCode":245,"cosmosGeoPoint":246,"geoPoint":250,"contacts":251},"CHALS-CCT UPR MScience","San Juan","00935","Puerto Rico","PR",{"type":40,"coordinates":247},[248,249],-66.10572,18.46633,{"lat":249,"lon":248},[252,255,257],{"name":253,"role":23,"phone":10,"phoneExt":10,"email":254},"Frances Aponte","frances.aponte2@upr.edu",{"name":256,"role":53,"phone":10,"phoneExt":10,"email":10},"Valerie Wojna, MD",{"name":258,"role":204,"phone":10,"phoneExt":10,"email":10},"Brenda Deliz, MD",{"type":260,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100449836","target-als-biomarker-study-longitudinal-biofluids-clinical-measures-and-at-home-measures-100449836",false,"NCT05137665","Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At Home Measures","Target ALS Biomarker Study; Longitudinal Biofluids, Clinical Measures, and At - Home Measures","TALSLB","ALS Participants:\n\n1. Age 18 or older.\n2. A diagnosis of ALS in accordance with Gold Coast criteria.\n3. Full Vital Capacity (FVC) of ≥30% or at the discretion of the Principal Investigator for the participant's predicted value for gender, height, and age at the time of screening.\n4. Ability to provide informed consent and understand the purpose and risks of the study.\n5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.\n\nHealthy Control Participants:\n\n1. Age 18 or older.\n2. No history of neurological disease, in the opinion of the Principal Investigator.\n3. No known ALS- associated genetic mutations at the time of consent.\n4. Ability to provide informed consent and understand the purpose and risks of the study.\n5. Ability to comply with study procedures and assessments, in the opinion of the Principal Investigator.",true,"ALL","18 Years",{"count":273,"type":274},1000,"ESTIMATED","5 Years","OBSERVATIONAL","The goal of the study is to generate a biorepository of longitudinal biofluids-blood (plasma and serum), cerebral spinal fluid (CSF) and urine linked to genetics and longitudinal clinical information that are made available to the research community. To accomplish these goals, we will enroll 800 Amyotrophic Lateral Sclerosis (ALS) patients and 200 healthy controls from sites globally, over a 5 year time frame. Additionally, speech and motor function and spirometry measures will be collected bi-weekly in a subset of participants. ALS participants will be asked to come to the clinic for 5 study visits approximately every 4 months. Healthy participants will be coming for 2 study visits with a 12-month interval between visits. These samples and clinical information will be stored in a de-identified manner and made available for investigators to use in future research studies.",[279,280,281,282],"Amyotrophic Lateral Sclerosis","Movement Disorders","Degenerative Disorder","Motor Neuron Disease",[279,284,285,286,32,287,288,289,290,291],"ALS Amyotrophic Lateral Sclerosis","Target ALS","Longitudinal Biofluids","New York Genome Center","Biofluids Biorepository","Genomic-wide association studies","observational study","Biofluid Samples","2025-11-20",{"date":294,"type":295},"2025-11-21","ACTUAL",{"date":297,"type":295},"2021-06-01",{"date":299,"type":274},"2031-12-31",{"name":5,"class":6},12]