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Identification of Diagnostic And Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples

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ClinicalTrials.gov Identifier: NCT01948102
Recruitment Status : Unknown
Verified July 2014 by Benjamin Brooks, Carolinas Healthcare System.
Recruitment status was:  Recruiting
First Posted : September 23, 2013
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of the project is to obtain skin and adipose tissue samples from patients with ALS to develop new diagnostic and prognostic markers of the disease. These samples will be obtained when percutaneous endoscopic gastrostomy (PEG) is performed as part of their standard of care. Skin and adipose tissue samples will also be obtained from disease control subjects who require a PEG as part of their standard of care.

Condition or disease
Amyotrophic Lateral Sclerosis

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Identification of Diagnostic and Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples
Study Start Date : July 2008
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015


Groups and Cohorts

Group/Cohort
subjects with ALS
subjects with ALS who are undergoing a percutaneous endoscopic gastrostomy
subjects without ALS
subjects without ALS who are undergoing a percutaneous endoscopic gastrostomy


Outcome Measures

Primary Outcome Measures :
  1. Abundance levels of the known messenger RNA transcriptome of skin and adipose tissue samples (measured by gene expression profiling) [ Time Frame: After tissue has been collected from study subjects. Data will be analyzed at 1 year. ]
  2. Changes in abundance of or post-translational modification of proteins (measured by proteomics) [ Time Frame: After tissue has been collected from study subjects. Data will be analzyed at year 1 after primary outcome data has been reviewed and analyzed ]

Biospecimen Retention:   Samples With DNA
skin and adipose tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at the Carolinas Neuromuscular/ALS-MDA Center and patients at Carolinas Medical Center.
Criteria

Inclusion Criteria:

  • for ALS patients, subjects must be diagnosed with definite ALS according to the El Escorial Critera (EEC)
  • all subjects must be diagnosed with a condition requiring PEG (percutaneous endoscopic gastrostomy) tube insertion
  • subjects must be older than 18 years of age

Exclusion Criteria:

  • children 18 years old and younger
Contacts and Locations

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): NCT01948102


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   
Sponsors and Collaborators
Benjamin Brooks
ALS Therapy Development Institute
Investigators
Principal Investigator: Thomas Pacicco, MD Carolinas Medical Center - Dept of Gastroenterology
More Information

Responsible Party: Benjamin Brooks, Director, Neuromuscular/ ALS-MDA Center and Neuromuscular/ ALS Research Laboratory, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT01948102     History of Changes
Other Study ID Numbers: CHS-Neurology_ALS_TDI_PEG
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

Keywords provided by Benjamin Brooks, Carolinas Healthcare System:
Amyotrophic Lateral Sclerosis
motor neuron disease
biological markers
biomarkers

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