Summary: Investigators are recruiting 100 individuals who are being evaluated for symptoms of MS or other neurological diseases for a study to determine the effectiveness of a new blood-based diagnostic test for MS. The study is funded by DioGenix, Inc., in partnership with the National MS Society through Fast Forward.
Rationale: Right now, there are no symptoms, physical findings or laboratory tests that can, by themselves, determine if a person has MS. Physicians must use several strategies in combination to determine if a person meets the criteria for a diagnosis of MS
, while ruling out other possible causes of the observed symptoms.
DioGenix is using an approach that may provide a more accurate diagnosis of MS at first clinical presentation and is based on the work of Dr. Nancy Monson and colleagues at The University of Texas Southwestern Medical Center, funded in part by the National MS Society. Dr. Monson and her team developed a DNA “signature” for MS – based on patterns of variations in certain immune genes – that might be used to identify people with relapsing-remitting MS early in their disease course. To date, this research has involved primarily analysis of spinal fluid, however Fast Forward has partnered with DioGenix to extend its novel approach and develop a blood-based test.
Eligibility and Details: Participants are people between the ages of 18 and 65 who are being evaluated by a physician for symptoms of MS or other neurological diseases which initially present in ways that are similar to MS. People are excluded who are pregnant, taking anticoagulation therapy or who have a history of a brain tumor. Further details on inclusion and exclusion criteria are available from the contact below.
Participants will undergo collection of blood and spinal fluid (obtained via lumbar puncture). The investigators are analyzing these samples for DNA signatures, and then are following the participants for up to three years to observe if they are diagnosed with MS, have accelerated disease progression or are not responding to therapy.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact Eric M. Eastman, Ph.D., Chief Science Officer, DioGenix, Inc., 15010 Broschart Road, Suite 200, Rockville, MD 20850, 301-370-2590, firstname.lastname@example.org
Sites are enrolling in the following cities:
South Shore Neurologic Associates
Missouri Baptist Medical Center
St. Louis, MO
Emory – Atlanta Veterans Affairs Medical Center
Beth Israel Deaconess Medical Center
University of Texas Southwestern Medical Center
University of Massachusetts Medical Center
Ohio State University
Montefiore MS Center
Kansas City MS Center
Overland Park, KS
University of Texas Health Science Center at San Antonio
San Antonio, TX
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF)