Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2015-04-01
2030-12-31
Brief Summary
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All people living with ALS or other MNDs who attend clinics at the Study hospitals (sites) are offered to participate in the Study.
The Sites collect so-called Baseline information including demographics, disease history and diagnosis, family history, etc. At each visit, the Sites also collect multiple disease-specific outcome measures and events. The information is captured in NeuroBANK, a patient-centric clinical research platform.
The Sites have an option to choose to collect data into 20+ additional forms capturing biomarkers and outcome measures. Captured data after its curation are anonymized (all personal identifiers and dates are being removed), and the anonymized dataset is shared with medical researchers via a non-exclusive revocable license.
Funding Source - Biogen, Inc.; Mitsubishi Tanabe Pharma America; FDA OOPD.
Detailed Description
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Upon obtaining consent, the following is done:
People with ALS/MND are assigned a Neurological Global Unique Identifier (NeuroGUID) and its study-specific derivative, NeuroSTAmP, which is used to link this Study's information to biological samples, images, and clinical data obtained from those individuals in this Study and other studies/trials, in which these patients participate(d).
The following information is captured in NeuroBANK platform:
Baseline information
* Longitudinal clinical and phenotypical data from routine clinical visits
* Longitudinal clinical and historical phenotypical data transcribed from electronic health records and notes
* Any other observational data that are of interest to the Investigator may be captured or linked to information in NeuroBANK.
Other Key Features
The site should track numbers of patients who declined participation. The site should have a mechanism in place to include an offer of participation to each patient in clinic (consenting does not require immediate data entry) Regular Data Quality checks may be performed at the site. Site personnel who intend to have access to NeuroBANK are trained and certified prior to given access.
Several registries, both cross-sectional and longitudinal, currently exist in ALS. NeuroBANK is distinct from other current registries in that it is a patient-centered platform that is designed to function as a data repository of patient data from clinical visits and multiple clinical research projects as well as linking these data to biorepository for tissue, imaging, and other biological information. This natural history study can act as a clinical research framework that may link clinical and clinical research data from current and past studies with biological specimens and image collections.
With obtained consents, biological specimens may be collected with bar-coded labels containing patient assigned study specific NeuroSTAmPs, printed from within NeuroBANK, and scanned into NeuroBANK's virtual distributed BioRepository module. Imaging studies are de-identified with NeuroSTAmPs and linked to clinical and phenotypical information. Anonymized clinical data obtained through this protocol are available to other researchers.
Study Population
Individuals who are seen during their clinical care visits are asked to allow their data to be uploaded and captured for clinical research. The NeuroBANK platform is located at and managed by the Center for Innovation and Bioinformatics (CIB), Neurological Clinical Research Institute (NCRI) of Massachusetts General Hospital (Boston, MA).
Consent Process
Every participant in the ALS clinic is approached to participate in this study. A signed informed consent form is obtained before any data are recorded for study purposes.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Other motor neuron disorders, including but not limited to Spinal-Bulbar Muscular Atrophy (SBMA, Kennedy's disease), Spinal Muscular Atrophy (SMA), Primary Lateral Sclerosis (PLS), Progressive Muscular Atrophy (PMA), and Progressive Bulbar Palsy (PBP)
Exclusion Criteria
18 Years
90 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Northwestern University
OTHER
Temple University
OTHER
St. Louis University
OTHER
University of Florida
OTHER
University of Minnesota
OTHER
Virginia Commonwealth University
OTHER
Fondazione Serena Onlus - Centro Clinico NeMO Milano
OTHER
Providence Health & Services
OTHER
University of Pittsburgh
OTHER
Istituti Clinici Scientifici Maugeri SpA
OTHER
Lahey Clinic
OTHER
Hadassah Medical Organization
OTHER
Tel Aviv Medical Center
OTHER
Kaiser Permanente
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Alexander Sherman
Director, Center for Innovation and Bioinformatics
Principal Investigators
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Alexander Sherman
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Loma Linda University Health
Loma Linda, California, United States
Kaiser Permanente
Los Angeles, California, United States
University of Florida
Gainesville, Florida, United States
Northwestern University
Chicago, Illinois, United States
Lahey Clinic
Burlington, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Saint Louis University
St Louis, Missouri, United States
Providence ALS Clinic
Portland, Oregon, United States
Temple University Lewis Katz School of Medicine
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Hadassah Medical Organization
Jerusalem, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
Centro Clinico NEMO Milano
Milan, , Italy
Istituti Clinici Scientifici Maugeri SpA
Milan, , Italy
Countries
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Central Contacts
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Facility Contacts
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Chris Greer
Role: primary
Jennifer Steshyn
Role: primary
Emma Schmidt
Role: primary
Sorieba Fofanah
Role: primary
Melo Catia
Role: backup
Anne Vallis
Role: primary
Valerie Ferment
Role: primary
Katie Forsman
Role: primary
Tyler Regan
Role: primary
John Furey
Role: primary
Helen Ismail
Role: primary
Demetrius Carter
Role: primary
Michal Zabari
Role: primary
Beatrice Abramovich
Role: primary
Monica Montuori
Role: primary
Camilla Garrè
Role: primary
Study Documents
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Document Type: Individual Participant Data Set
View DocumentRelated Links
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ALS/MND NATURAL HISTORY CONSORTIUM
Other Identifiers
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2013P001670
Identifier Type: -
Identifier Source: org_study_id
2022A011556
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2022A018800
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id