Pennsylvania Consortium: Clinical Database

This study has been terminated.
(Terminated due to lack of funding and support staff)
Sponsor:
Collaborator:
MDA/ALS Center of Hope
Information provided by (Responsible Party):
Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier:
NCT00718445
First received: July 16, 2008
Last updated: May 1, 2014
Last verified: March 2013
  Purpose

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.


Condition
Amyotrophic Lateral Sclerosis
Neurodegenerative Disease
Motor Neuron Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Pennsylvania Consortium: Clinical Database

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • None Specified [ Time Frame: None Specified ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: March 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718445

Locations
United States, Pennsylvania
MDA/ALS Center of Hope
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Drexel University College of Medicine
MDA/ALS Center of Hope
  More Information

No publications provided

Responsible Party: Drexel University ( Drexel University College of Medicine )
ClinicalTrials.gov Identifier: NCT00718445     History of Changes
Other Study ID Numbers: Internal-17445
Study First Received: July 16, 2008
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Amyotrophic Lateral Sclerosis
Cerebrospinal Fluid
Neurodegenerative Disease
Motor Neuron Disease
Autonomic Nervous System
Neurodegenerative Diseases
Movement Disorders

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Neurodegenerative Diseases
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014