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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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