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

• ClinicalTrials.gov Identifier: NCT01948102
• Recruitment Status: Unknown
• First Posted: September 23, 2013
• Last Update Posted: July 3, 2014
• Sponsor: Benjamin Brooks
• 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

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

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