Pennsylvania Consortium: Clinical Database

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Pennsylvania Consortium: Clinical Database

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718445
• Other study ID #: Internal-17445
• Status: Terminated
• Phase: N/A
• First received: July 16, 2008
• Last updated: June 23, 2016
• Start date: March 2008
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Drexel University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neurodegenerative Disease
• Neurodegenerative Diseases

Locations

Country	Name	City	State
United States	MDA/ALS Center of Hope	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Drexel University College of Medicine	MDA/ALS Center of Hope

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No