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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Carolinas Healthcare System
Sponsor:
Collaborator:
ALS Therapy Development Institute
Information provided by (Responsible Party):
Benjamin Brooks, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT01948102
First received: March 30, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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
Amyotrophic Lateral Sclerosis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Identification of Diagnostic and Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

skin and adipose tissue


Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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

ClinicalTrials.gov processed this record on August 28, 2014