Pennsylvania Consortium: Clinical Database

In order to streamline disease research in ALS and other motor neuron diseases, we have joined a consortium of clinical centers (Hershey and University of Pittsburgh) who will collaborate on clinical and basic research projects. As part of this collaboration, de-identified clinical data from subjects at each institution will be entered into a joint database kindly provided and maintained by the ALS Hope Foundation. This database is password protected and contains only de-identified information. In addition to clinical data, any research specimens that are available through IRB approved tissue collections will be linked to the subject so that the collaborating investigators can share samples and have the maximum information. This will enhance the usefulness of each specimen.

Once established, the database will provide a resource in which clinical data on a large number of patients along with tissue (blood, urine, muscle, csf, and autopsy) samples will be readily available. This will expedite research by circumventing the delays in collecting specimens prospectively and increase the number of specimens available by allowing the collaborating researchers access to each others specimens. In each case there will be a formal request placed to use specimens that are at the other institutions. These specimens will be used for research in the ALS Center of Hope at the Drexel University College of Medicine and shared with outside investigators with valid IRB approved protocols.

Study Overview

• Status: Terminated
• Conditions: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Disease

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • MDA/ALS Center of Hope

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients seen in the MDA/ALS Center of Hope at Drexel University College of Medicine Patients seen in the Department of Neurology at Drexel University College of Medicine

Description

Inclusion Criteria:

• Clinical data on patients with motor neuron diseases (ALS, PLS, Bulbar Palsy) and related disorders

Exclusion Criteria:

• Any patient without a motor neuron disease or related disorder

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MND; Patients seen in the MDA/ALS Center of Hope at Drexel University College of Medicine; Patients seen in the Department of Neurology at Drexel University College of Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
None Specified	This database is intended to increase the efficiency of other IRB approved protocols by increasing accessibility of information and biological samples from the ALS cohort. No direct outcome measures have been specified for the creation of the database.	None Specified

Collaborators and Investigators

• Sponsor: Drexel University College of Medicine
• Collaborators: MDA/ALS Center of Hope

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; Motor Neuron Disease; Autonomic Nervous System; Neurodegenerative Disease; Movement Disorders; Neurodegenerative Diseases; Cerebrospinal Fluid
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Neurodegenerative Diseases
• Other Study ID Numbers: Internal-17445