Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 521 for:    ALS (Amyotrophic Lateral Sclerosis)

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

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: NCT01948102
Recruitment Status : Unknown
Verified July 2014 by Benjamin Brooks, Atrium Health.
Recruitment status was:  Recruiting
First Posted : September 23, 2013
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
ALS Therapy Development Institute
Information provided by (Responsible Party):
Benjamin Brooks, Atrium Health

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

Layout table for study information
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


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



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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
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

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
Layout table for location contacts
Contact: Cynthia Lary 704-446-6063 cynthia.lary@carolinashealthcare.org

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Thomas Pacicco, MD Carolinas Medical Center - Dept of Gastroenterology

Layout table for additonal information
Responsible Party: Benjamin Brooks, Director, Neuromuscular/ ALS-MDA Center and Neuromuscular/ ALS Research Laboratory, Atrium Health
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, Atrium Health:
Amyotrophic Lateral Sclerosis
motor neuron disease
biological markers
biomarkers
Additional relevant MeSH terms:
Layout table for MeSH terms
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases