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Trial record 41 of 526 for:    ALS (Amyotrophic Lateral Sclerosis)

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, 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

Tracking Information
First Submitted Date March 30, 2013
First Posted Date September 23, 2013
Last Update Posted Date July 3, 2014
Study Start Date July 2008
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2013)
  • 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. ]
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01948102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identification of Diagnostic And Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples
Official Title Identification of Diagnostic and Prognostic Biomarkers From Amyotrophic Lateral Sclerosis (ALS) Skin and Adipose Samples
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.
Detailed Description Not Provided
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
skin and adipose tissue
Sampling Method Non-Probability Sample
Study Population Patients at the Carolinas Neuromuscular/ALS-MDA Center and patients at Carolinas Medical Center.
Condition Amyotrophic Lateral Sclerosis
Intervention Not Provided
Study 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: September 18, 2013)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01948102
Other Study ID Numbers CHS-Neurology_ALS_TDI_PEG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Benjamin Brooks, Atrium Health
Study Sponsor Benjamin Brooks
Collaborators ALS Therapy Development Institute
Investigators
Principal Investigator: Thomas Pacicco, MD Carolinas Medical Center - Dept of Gastroenterology
PRS Account Atrium Health
Verification Date July 2014