TRIAL READY (Clinical Trial Readiness)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03912987|
Recruitment Status : Active, not recruiting
First Posted : April 12, 2019
Last Update Posted : June 27, 2022
|Condition or disease|
|Amyotrophic Lateral Sclerosis Frontotemporal Dementia ALS-Frontotemporal Dementia Primary Lateral Sclerosis Progressive Muscular Atrophy|
|Study Type :||Observational|
|Estimated Enrollment :||610 participants|
|Official Title:||TRIAL READY (Clinical Trial Readiness)|
|Actual Study Start Date :||January 22, 2019|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||June 2023|
Affected with ALS or a related disorder, including ALS-FTD, FTD, PLS, and PMA.
Those never diagnosed with and not at particular risk for developing ALS or a related disorder.
- Longitudinal trajectories (and variability) of leading biological-fluid biomarker candidates. [ Time Frame: 12 months ]In a population of patients with ALS and related disorders who would meet typical clinical trial eligibility, this study aims to define the natural history (and variability) of urinary neurotrophin receptor extracellular domain (p75ECD); blood and cerebrospinal fluid (CSF) neurofilament light (NfL) and phosphorylated neurofilament heavy (pNfH); and among patients with the C9orf72 hexanucleotide repeat expansion mutation (HREM), CSF and peripheral blood mononuclear cell (PBMC) poly(GP).
- Prognostic utility of leading biological-fluid biomarker candidates. [ Time Frame: 12 months ]In a population of patients with ALS and related disorders who would meet typical clinical trial eligibility, quantify the prognostic value that baseline biomarker levels add to readily available clinical factors that are known to predict prognosis.
Biospecimen Retention: Samples With DNA
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): NCT03912987
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Kansas|
|University of Kansas|
|Kansas City, Kansas, United States, 66160|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Michael Benatar||University of Miami|