- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067179
Analysis of Human ALS Tissues and Registry of ALS Patients
Study Overview
Status
Conditions
Detailed Description
Patients will be approached during in-person or phone/online appointments and asked their consent to enter information and results from their physical examinations, electrodiagnostic testing, and other testing done as a standard of care and into a database to monitor disease progression and use them for research purposes. Also, the patients will be asked for consent to undergo a MRI scan.
In a second informed consent form, patients will be enrolled to perform a rapid postmortem autopsy and have the tissue banked for research purposes. It is important to keep the consents separate because some patients may not consent to this postmortem study, but would consent to the premortem studies.
The information gained from the premortem studies will be used during the postmortem examination to select tissue for further processing. Tissue from different regions, including brain, spinal cord, nerve and muscle will be processed in parallel for cellular and molecular analyses that include histology, immunostaining, in situ hybridization, protein, RNA, and small molecule analyses.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Samreen Ahmed
- Phone Number: 312-413-1882
- Email: sa50@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois at Chicago
-
Contact:
- Samreen Ahmed
- Phone Number: 312-413-1882
- Email: sa50@uic.edu
-
Sub-Investigator:
- Charles Abrams, MD, PhD
-
Sub-Investigator:
- Diana Mnatsakanova, MD
-
Sub-Investigator:
- Pritikanta Paul, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients over the age of 18
- Established diagnosis of ALS
- Able and willing to give written informed consent and must authorize release and use of protected health information
Exclusion Criteria:
- Patients below the age of 18
- No diagnosis of ALS
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Imaging biomarkers
Time Frame: Within 6 months of participant enrollment
|
High resolution 3T MRI T1, T2/FLAIR, DWI, SWI, MRS, and MT sequences at the cervical, thoracic, and lumbar spine and brainstem will be used to identify individual and combinatorial (of each sequence) changes to be used as clinical biomarkers of progression in cases with focal disease onset and spread.
These will be compared to histologic and genomic changes in rapid postmortem tissues in the same areas.
High resolution T1-weighted imaging is preferred for anatomical structure morphometry.
The hypothesis is that spinal cord cross-sectional area decreases over time may be a sensitive MRI parameter to detect progression and respiratory distress.
The aim is to develop a highly sensitive and specific, non-invasive measure of ALS progression in the spinal cord using a multi-parametric measurement scheme.
Image sequences will be attained and a combinatorial statistical analysis performed to find the best biomarker of progression that could differ regardless of upper motor neuron involvement.
|
Within 6 months of participant enrollment
|
Molecular biomarkers
Time Frame: Within 12 months of participant's passing
|
Tissue analyses will be performed to identify differentially expressed genes and histological differences from a rapid postmortem analysis of human ALS tissues from the same spinal cord levels and brainstem imaged on MRI, using an initial genomic analysis (RNAseq).
Clinically meaningful biomarkers for disease progression will be validated through bioinformatics and confirmatory studies on human tissues and linked to imaging and clinical findings.
Further analysis will look for differences in those with and without upper motor neuron involvement and for those taking or not taking drugs.
Tissues will be stored for future studies.
|
Within 12 months of participant's passing
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jeffrey Loeb, MD, University of Illinois at Chicago
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-0748
- 097064 (Other Grant/Funding Number: Mitsubishi Tanabe Pharma America, Inc.)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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