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Clinical Procedures to Support Research (CAPTURE)

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ClinicalTrials.gov Identifier: NCT03489278
Recruitment Status : Recruiting
First Posted : April 5, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
Muscular Dystrophy Association
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Advancing Translational Science (NCATS)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Michael Benatar, University of Miami

Brief Summary:
The purpose of the Clinical Procedures To Support Research (CAPTURE) study is to utilize information collected in the medical record to learn more about a disease called amyotrophic lateral sclerosis (ALS) and related disorders.

Condition or disease
Amyotrophic Lateral Sclerosis ALS-Frontotemporal Dementia Primary Lateral Sclerosis Progressive Muscular Atrophy

Detailed Description:
The study will consent patients with ALS or related disorders that are receiving care at a clinical center in the CReATe consortium that uses Epic as its electronic health record (EHR) system. The study aims to systematically gather a clinical dataset through the EHR using a standardized approach to characterize the natural history of ALS and related diseases.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Procedures to Support Research (CAPTURE)
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021


Group/Cohort
Affected
Affected with ALS or a related disorder.



Primary Outcome Measures :
  1. Using the ALS Toolkit for collecting and using electronic health record data for research purposes [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
Optional: Provide blood for a DNA sample during a clinic visit. Participants can choose to allow collection of information from their medical record, but choose not to give a blood sample for testing.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Affected patients receiving care at a clinical center that uses Epic as EHR.
Criteria

Inclusion Criteria:

  • Diagnosis of ALS or a related disorder (e.g. primary lateral sclerosis, progressive muscular atrophy).
  • Receiving care at a clinical center that uses Epic as its EHR.
  • Able and willing to provide informed consent (or informed consent obtainable from a designated proxy).

Exclusion Criteria:

  • Inability to understand English and/or Spanish

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03489278


Contacts
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Contact: Michael Benatar, MBChB, MS, DPhil 1-844-837-1031 projectcreate@miami.edu
Contact: Sumaira Hussain 1-844-837-1031 projectcreate@miami.edu

Locations
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United States, California
California Pacific Medical Center Recruiting
San Francisco, California, United States, 94115
Contact: Simon Carty    415-600-1368    cartys@sutterhealth.org   
Principal Investigator: Jonathan Katz, MD         
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Anne-Laure Grignon    305-243-8928    projectcreate@miami.edu   
Principal Investigator: Michael Benatar, MBChB, MS, DPhil         
Sponsors and Collaborators
University of Miami
Muscular Dystrophy Association
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Advancing Translational Science (NCATS)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Michael Benatar, MBChB, MS, DPhil University of Miami

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Responsible Party: Michael Benatar, Chief, Neuromuscular Division, University of Miami
ClinicalTrials.gov Identifier: NCT03489278     History of Changes
Other Study ID Numbers: 20170785
U54NS092091 ( U.S. NIH Grant/Contract )
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Atrophy
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Muscular Atrophy
Frontotemporal Dementia
Aphasia, Primary Progressive
Pick Disease of the Brain
Muscular Atrophy, Spinal
Pathologic Processes
Pathological Conditions, Anatomical
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Frontotemporal Lobar Degeneration
Dementia
Brain Diseases
Neurocognitive Disorders
Mental Disorders
Aphasia
Speech Disorders
Language Disorders