Spastic Paraplegia - Centers of Excellence Research Network
NCT ID: NCT06553976
Last Updated: 2024-12-13
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
100 participants
OBSERVATIONAL
2024-06-04
2027-06-04
Brief Summary
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Detailed Description
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The Spastic Paraplegia - Centers of Excellence Research Network (SP-CERN) is a collaborative research consortium dedicated to advancing the understanding, diagnosis, and treatment of hereditary spastic paraplegia (HSP) and primary lateral sclerosis (PLS). SP-CERN provides a registry and natural history study across the whole age span, a biobank, and a genome archive. This will set the stage for a multitude of opportunities for improved diagnosis and trial readiness. A second objective is to harmonize this effort with similar consortia, especially in Europe, in addition to Asia, South America, and Africa, to help accelerate basic and clinical research on HSP and PLS on a global level. In summary, SP-CERN will support critical research infrastructure for collaborative high-quality research on HSP and PLS in North America and beyond.
General aims include:
A. Establish a shared clinical database, a repository of biospecimen samples, and a central database for the storage of all genetic data in SP-CERN.
B. Synchronize and harmonize collaborations between institutions, clinical sites, and international collaborators through the development of a central research protocol in order to standardize outcome measures and maximize the quality of research and data to ensure clinical trial readiness by regulatory standards.
C. Build comprehensive programs for advancements in diagnosis, provide more opportunities for innovative treatments, and increase access to high-quality healthcare for HSP and PLS patients.
Specific aims for this first pilot study are:
1a. Enrollment of 100 individuals with genetically-confirmed hereditary spastic paraplegia type 4 (SPG4) or hereditary spastic paraplegia type 5A (SPG5A) in the shared clinical database.
1b. Biobanking of blood samples from 100 individuals with SPG4 or SPG5A in a shared biobank.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Columbia University
OTHER
University of Miami
OTHER
University of Michigan
OTHER
Baylor College of Medicine
OTHER
University of Texas Southwestern Medical Center
OTHER
University of Washington
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Seattle Children's Hospital
OTHER
University of Iowa
OTHER
Boston Children's Hospital
OTHER
Responsible Party
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Darius Ebrahimi-Fakhari
Principal Investigator
Locations
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University of Miami Miller School of Medicine
Miami, Florida, United States
University of Iowa Carver College of Medicine
Iowa City, Iowa, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan School of Medicine
Ann Arbor, Michigan, United States
Columbia University - Irving Medical Center
New York, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Scottish Rite for Children
Dallas, Texas, United States
Texas Children's Hospital
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Washington School of Medicine
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Stephan Züchner, MD, PhD.
Role: primary
Yeisha Arcia, BS.
Role: backup
Michael Shy, MD.
Role: primary
Nicole Kressin, MA.
Role: backup
Darius Ebrahimi-Fakhari, MD, PhD.
Role: primary
Nicole Battaglia, BS.
Role: backup
Craig Blackstone, MD, PhD.
Role: primary
John Fink, MD.
Role: primary
Matthew Harms, MD.
Role: primary
Donald Gilbert, MD.
Role: primary
Christi Banks, CIP
Role: backup
Michelle Christie, MD.
Role: primary
Linsley Smith, BS.
Role: backup
Daniel Calame, MD, PhD.
Role: primary
Taylor Leonard, BS.
Role: backup
Dararat Mingbunjerdsuk, MD.
Role: primary
Jacquline Lee-Eng, BS.
Role: backup
Marie Davis, MD, PhD
Role: primary
Sarah Simon, BS.
Role: backup
Related Links
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Spastic Paraplegia - Centers of Excellence Research Network Website
Other Identifiers
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P00047458
Identifier Type: -
Identifier Source: org_study_id