Researchers will prospectively assess clinical information, MRI data, blood biomarkers, and genetic variables to evaluate risk factors that affect MS disease progression.
AMSTERDAM—Researchers have established the Serial Unified Multicenter Multiple Sclerosis (MS) Investigation (SUMMIT) international consortium to prospectively evaluate risk factors that affect disease progression in a large, multinational cohort of patients with MS, according to a presentation at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in MS.
“Such longitudinal studies will be needed to understand disease progression in the modern era of treatment,” Howard L. Weiner, MD, Professor of Neurology at Harvard Medical School in Boston, and his colleagues noted.
Evaluating Disease Progression Factors
To predict factors affecting disease progression, Dr. Weiner’s team will assess clinical information, MRI data, blood biomarkers, and genetic variables from 1,500 patients with MS enrolled at international MS Centers in Boston; San Francisco; Basel, Switzerland; and Amsterdam. Each European site will contribute 250 patients to the SUMMIT study, while each US site will contribute 500 patients.
“We hope to present initial results at next year’s ECTRIMS, and we hope the SUMMIT will follow patients for at least a decade,” Dr. Weiner told Neurology Reviews.
Data collection for the study began in 2011, and the sites will maintain communication throughout the process with conference calls and bi-annual meetings.
Each year, the researchers will collect standardized clinical data on all patients, including medical and family history, the date and features of disease onset, relapse details, and current and historical treatments. The investigators will also analyze results obtained from the Symbol Digit Modalities Test, the Ambulation Index, and the Expanded Disability Status Scale (EDSS).
In addition, Dr. Weiner’s team developed a standardized questionnaire to obtain information about patient demographics, as well as epidemiologic factors such as alcohol and smoking history, diet and allergies, vitamin D intake, and vaccination history. To evaluate influences specific to females, the study will obtain data on menses onset, pregnancy, breast-feeding, fertility treatments, menopause, and hormone medications.
Biologic samples from all participants will be collected to assess antigen microarrays, RNA microarrays, vitamin D levels, and serum biomarkers, and MRI will be used to measure T2 lesion volume, normalized brain volume, and gadolinium-enhancing lesions. The researchers added that, “A genome-wide meta-analysis for single nucleotide polymorphisms that influence clinical and MRI outcome measures is planned.”
Current Progress and Future Outcomes
Thus far, the SUMMIT study has made some progress toward its goals. The team obtained institutional review board (human studies) approval, established a data collection platform and uniform collection forms and fields, and created working groups.
The research group anticipates using statistical methodologies and computerized analysis software to analyze univariate and multivariate predictors of disease progression. “We think that MRI, biomarkers, and clinical features of the patients will be the most influential,” Dr. Weiner commented.
The investigators expect to add more collaborative partners to the study in the future. Dr. Weiner explained, “Once the SUMMIT structure has been firmly established and is operational, which should take approximately one more year, we will be talking to other MS centers to see if any are interested in participating and how to provide for long-term funding.
“We hope the clinical implications will relate to understanding the course of disease in individual patients and how to modify factors that will affect long-term progression,” he concluded.
—Lauren LeBano