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
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Sponsor:
Benjamin Brooks
Collaborator:
ALS Therapy Development Institute
Information provided by (Responsible Party):
Benjamin Brooks, Atrium Health
Tracking Information | ||||
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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 |
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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
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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 |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Unknown status | |||
Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Atrium Health | |||
Verification Date | July 2014 |