Trial record 6 of 419 for:    Motor Neuron Diseases

Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND) (WBC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Carolinas Healthcare System
Sponsor:
Information provided by (Responsible Party):
Benjamin Brooks, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01950910
First received: March 30, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

Amyotrophic lateral sclerosis (ALS) is a motor neuron disease characterized by progressive degeneration of motor neurons, muscle atrophy and paralysis. There is no reliable early diagnostic test for ALS, making identification of the disease difficult at its earliest stages. Early detection is critical to the initiation of early neuroprotective therapy. By the time a reliable diagnosis can be made, substantial damage to motor neurons and muscle has already occurred. The purpose of the current project is to establish a bank of blood samples (serum and protein/RNA/DNA from blood cells) and CSF for use in the development of an early diagnostic test for ALS and for better understanding the progression of this disease. The main idea of the current study is to examine samples from patients that have a suspected diagnosis of motor neuron disease, including patients with ALS who have not progressed far enough to be definitively diagnosed as having ALS. Normal and disease control samples will be collected for comparison. The investigators will examine various biochemical and metabolic markers from these samples, in hopes of finding differences in their expression between control subjects and ALS patients and during disease progression. Ultimately, the investigators would like to have a panel of markers from the blood that would allow us to diagnose and follow the progression of ALS from the earliest possible moment. The data collected from this project would give us a basis for a fairly non-invasive, quick and clinically relevant test for the early diagnosis of ALS. This in turn would allow us to provide earlier intervention for these patients, possibly slowing the damage and improving prognosis.


Condition
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Establishment of a Tissue Bank (Blood, CSF) for the Understanding of the Disease Progression and Early Diagnosis of Motor Neuron Disease (MND).

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Levels of ALS biomarkers in CSF [ Time Frame: After CFS is collected from study subjects. Data will be analyzed at one year. ] [ Designated as safety issue: No ]
  • Leves of ALS biomarkers in blood [ Time Frame: After blood is collected from study subject. Data will be analyzed at one year. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood samples (serum and protein/RNA/DNA from blood cells) and CSF


Estimated Enrollment: 1000
Study Start Date: June 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
subjects w/ non-motor neurodegen disease
subjects with ALS or with non-motor neurodegenerative disease
subjects w/out motorneuron degenerative dis
subjects without motorneuron degenerative disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

ALS patients in the Charlotte, NC, area.

Criteria

Inclusion Criteria:

  • 18 years old or older

Exclusion Criteria:

  • less than 18 years old
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950910

Contacts
Contact: Cynthia Lary 704-446-6063 cynthia.lary@carolinashealthcare.org

Locations
United States, North Carolina
Carolinas Medical Center - Dept of Neurology Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Cynthia Lary    704-446-6063    cynthia.lary@carolinashealthcare.org   
Principal Investigator: Benjamin Brooks, MD         
Sponsors and Collaborators
Benjamin Brooks
Investigators
Principal Investigator: Benjamin Brooks, MD Carolinas Medical Center - Neurology
  More Information

No publications provided

Responsible Party: Benjamin Brooks, Medical Director, Neuromuscular/ALS-MDA Center and Neuromuscular/ALS Research Laboratory, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01950910     History of Changes
Other Study ID Numbers: CHS-Neurology-WBC Tissue Bank
Study First Received: March 30, 2013
Last Updated: July 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Carolinas Healthcare System:
Amyotrophic lateral sclerosis
motor neuron disease
biological markers
biomarkers

Additional relevant MeSH terms:
Motor Neuron Disease
Disease Progression
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Metabolic Diseases
Disease Attributes
Sclerosis
Amyotrophic Lateral Sclerosis
Pathologic Processes
TDP-43 Proteinopathies
Proteostasis Deficiencies

ClinicalTrials.gov processed this record on September 18, 2014