Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS) (BIO_ALS-01)

Study Purpose:

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP), Healthy Volunteer, Disease Mimics of ALS

Study Type:

Observational Study

Study Category:

Biomarkers/Imaging

Study Status:

Not enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
James D. Berry, MD, PhD (Massachusetts General Hospital)
Robert Bowser, PhD (Barrow Neurological Institute)

Clinicaltrials.gov ID (11 digit #):

NCT00677768

Neals Affiliated?

Yes

Coordinating Center Contact Information

NCRI at the Massachusetts General Hospital
Daniela Grasso / .(JavaScript must be enabled to view this email address) / 617-726-0842
.(JavaScript must be enabled to view this email address) 149 13th Street, BLDG 149, MGH East
Boston, Massachusetts 02129 United States

Full Study Summary:

The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as other neurodegenerative diseases and from people with no neurological disorder. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to diagnose ALS and monitor disease progression.

Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis. Studying components of the blood, such as DNA, may help us understand what happens when genes function abnormally and how it might be related to disease.

Study Sponsor:

ALSA, ATA, NIH

Participant Duration:

Up to 36 months

Estimated Enrollment:

650

Estimated Study Start Date:

04/30/2008

Estimated Study Completion Date:

11/02/2016

Posting Last Modified Date:

11/30/2011

Date Study Added to alsconsortium.org:

10/31/2011

More Information
Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers with neurological diseases other than ALS. These changes are called biomarkers. Biomarkers for ALS have been found in blood collected in earlier phases of this study. Biomarkers are non-genetic elements in your blood that may help to make diagnosing ALS easier. In the next phase, comparison of these changes in the blood of volunteers with ALS and without ALS will be used to confirm these biomarkers and to develop a tool to diagnose and monitor progression of ALS.
Eligibility Criteria

Gender:
Female, Male
Minimum Age:
30
Maximum Age:
80

Time since Symptom Onset:
<36 months
Time since Diagnosis:

Can participants use Riluzole?
Yes

Medically safe to have lumbar puncture
Site Contact Information

Phoenix Neurological Associates, Ltd
Todd Levine, MD / Nicole Hank, MHMS / .(JavaScript must be enabled to view this email address) / 602-258-2432 / 602-258-2432
5090 N. 40th Street Suite 250
Phoenix, Arizona 85018
United States

UC Irvine MDA ALS and Neuromuscular Center
Tahseen Mozaffar, MD / Veronica Martin / .(JavaScript must be enabled to view this email address) / 714-456-5214 / 714-456-7760
200 S Manchester Avenue Suite 110
Orange, California 92868
United States

Mayo Clinic Neurology
Kevin Boylan, MD / Thomas Kryston / .(JavaScript must be enabled to view this email address) / 904-953-6915 / 904-953-8344
Cannaday 2E
Jacksonville, Florida 32224
United States

University of Miami Miller School of Medicine
Khema Sharma, MD / Donald Koggan, MD / .(JavaScript must be enabled to view this email address) / 305-243-5586 / 305-243-7424
Clinical Research Building, 1375-1
Miami, Florida 33136
United States

Emory University
Jonathan Glass, MD / Latoya Shaw / Crystal Richards / .(JavaScript must be enabled to view this email address) / 404-727-3507 / 404.727.1673 / 404-727-3813
The ALS Center at Emory University
Atlanta, Georgia 30322
United States

University of Chicago Medical Center
Raymond Roos, MD / Koroush Rezania, MD / Ismael Gutierrez / .(JavaScript must be enabled to view this email address) / 773-702-5659 / 773-702-9200 / 773-834-4654
Department of Neurology
Chicago, Illinois 60637
United States

Johns Hopkins University - ALS Clinic
Nicholas Maragakis, MD / Elizabeth (Betsy) Mosmiller / .(JavaScript must be enabled to view this email address) / 410-614-9874 / 410-502-0495
601 N. Caroline Street
Baltimore, Maryland 21205
United States

Lahey Clinic
James Russell, DO / Stephanie Scala / .(JavaScript must be enabled to view this email address) / 781-744-8632 / 781-744-2950
31 Mall Road
Burlington, Massachusetts 01805
United States

Massachusetts General Hospital
Merit Cudkowicz, MD, MSc / James Berry, MD, PhD / Robert Lawson / .(JavaScript must be enabled to view this email address) / 617-724-1873 / 617-726-5097 / 617-726-0563
149 13th Street CNY, Room 2274
Charlestown, Massachusetts 02129
United States

Saint Mary's Healthcare
Deborah Gelinas, MD / Brian Berryhill, PharmD. / .(JavaScript must be enabled to view this email address) / 616-685-5314 / 616-685-5435
Neuroscience Program
Grand Rapids, Michigan 220 Cherry Street, SE
United States

Hennepin County Medical Center / Berman Center
Ezgi Tiryaki, MD / Cindy Rohde / .(JavaScript must be enabled to view this email address) / 612-873-2595 #4 / 612-341-7923
825 South 8th Street, Suite 440
Minneapolis, Minnesota 55404
United States

St Louis University
Ghazala Hayat, MD / Susan Eller, MA, RN / .(JavaScript must be enabled to view this email address) / 314-977-4860 / 314-977-4867
1438 South Grand CRU 3rd Floor
St Louis, Missouri 63104
United States

Washington University Medical School
Alan Pestronk, MD / Julaine Florence, DPT, PT / Charlie Wulf / Pamela Townsend / .(JavaScript must be enabled to view this email address) / 314-362-6981 / 314-362-6983 / 314-362-6980
660 S. Euclid Avenue Box 8111
St Louis, Missouri 63110
United States

Dartmouth Hitchcock Medical Center
Brent Harris, MD / .(JavaScript must be enabled to view this email address) / 603-650-0889
Dartmouth Medical School
Lebanon, New Hampshire 03756
United States

UMDNJ Robert Wood Johnson Medical School
Jerry Belsh, MD / Barbara Belsh / .(JavaScript must be enabled to view this email address) / 732-235-7340 / 732-235-7234
Department of Neurology
New Brunswick, New Jersey 08901
United States

Upstate Clinical Research, LLC
James Wymer, MD / Suzanne Alterman, RN, BSN / .(JavaScript must be enabled to view this email address) / 518-438-0922 / 518-533-1546
3 Atrium Drive Suite 205
Albany, New York 12205
United States

Beth Israel Medical Center, PACC
Stephen Scelsa, MD / Theresa Imperato / .(JavaScript must be enabled to view this email address) / 212-844-8490 / 516-946-5467
10 Union Square East Suite 5D
New York, New York 10003
United States

SUNY Upstate Medical University
Jeremy Shefner, MD / Katie Markis / Mary Lou Watson, RRT / .(JavaScript must be enabled to view this email address) / 315-464-5302 / 315-464-4998 / 315-464-5004
Institute for Human Performance Clinical Research Unit
Syracuse, New York 13210
United States

Carolinas Health Care
Benjamin Brooks / Jaime Shue, RN, BSN / Brent Harris, MD / .(JavaScript must be enabled to view this email address) / 704-446-1910 / 704-446-6253 / 603-650-0889
1010 N. Edgehill Road
Charlotte, North Carolina 28207
United States

Duke University Medical Center
Richard Bedlack, MD / Karen Grace, RN / .(JavaScript must be enabled to view this email address) / 919-668-2639 / 919-668-2844
Neuroscience Clinical Research Organization
Durham, North Carolina 27705
United States

Wake Forest University Baptist Medical Center
James Caress, MD / Mozhdeh Marandi, MD, CCRC / Theresa Johnston-Crews, RN, MSN / .(JavaScript must be enabled to view this email address) / 336-716-6704 / 336-713-8577 / 336-716-2323
Medical Center Boulevard
Winston-Salem, North Carolina 27157
United States

OSU Medical Center / Dept of Neurology
Stephen Kolb, MD / Sharon Chelnick / .(JavaScript must be enabled to view this email address) / 614-293-4969 / 614-293-4973
395 W 12th Avenue 7th Floor
Columbus, Ohio 43210
United States

Oregon Health & Science University
Jau-Shin Lou, MD, PhD / Diana Dimitrova / .(JavaScript must be enabled to view this email address) / 503-494-1769 / 503-494-7269
Dept of Neurology CR-120
Portland, Oregon 97233
United States

Providence ALS Center
Kimberly Goslin, MD / Britt Ash, RN, BSN / .(JavaScript must be enabled to view this email address) / 503-963-3100 / 503-963-3128
5050 NE Hoyt Suite 315
Portland, Oregon 97213
United States

Pennsylvania State University
Zachary Simmons, MD / Kevin Scott, MD / Helen (Beth) Stephens, MA / .(JavaScript must be enabled to view this email address) / 717-531-1802 / / 717-531-0003 x283395
Penn State Hershey Neuroscience Clinics, EC120, Room 1304
Hershey, Pennsylvania 17033
United States

Drexel University College of Medicine
Terry Heiman-Patterson, MD / Christine Barr, RN / .(JavaScript must be enabled to view this email address) / 215-762-7692 / 215-762-5186
219 North Broad Street
Philadelphia, Pennsylvania 19107
United States

University of Pittsburgh
David Lacomis, MD / Danielle Rowlands, RN, BSN / .(JavaScript must be enabled to view this email address) / 412-647-1706 / 412-648-9053
BST S-514
Pittsburgh, Pennsylvania 15213
United States

Methodist Neurological Institute
Milvia Pleitez, MD / Luis Lay, Jr / Sharon Halton / .(JavaScript must be enabled to view this email address) / 713-441-3335 / 713-441-3057 / 713-441-3420
6560 Fannin, Suite 802
Houston, Texas 77030
United States

University of Utah
Mark Bromberg, MD / Narneice Craven / .(JavaScript must be enabled to view this email address) / 801-585-5885 / 801-585-7876
30 North 1900 East
Salt Lake City, Utah 84132
United States

Montreal Neurological Institute
Angela Genge, MD / Jo-Wen Wang / .(JavaScript must be enabled to view this email address) / 514-398-3868 / 514-398-1779
380 University Street Suite 207
Montreal, Quebec H3A 2B4
Canada