Special Projects & Programs

CIRCLES Biorepository

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CIRCLES stands for the Collaborative International Research in Clinical and Longitudinal Experience in NMO Studies. The purpose of the CIRCLES study is to create a biorepository containing longitudinally-collected data and bio samples from subjects with NMO and control subjects. The data and bio samples will be available to researchers to better understand NMO pathogenesis, clinical course, and impact of therapy. Results of these studies may identify the etiology and risk factors, biomarkers for disease progression, and treatment outcomes to guide development of novel therapies. Findings may also facilitate future research and clinical trials to investigate specific hypotheses related to NMO and to improve the lives of individuals suffering from NMO.

Program Goals

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Enroll volunteer NMO patients and controls into the CIRCLES study to collect biosamples and/or associated clinical information donors.
Facilitate prospective longitudinal observational studies designed to improve understanding of etiology, pathogenesis & biomarkers of NMO.
Support industry efforts to develop improved therapeutic agents and strategies that benefit patients with NMO.

Program Details

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Expand the GJCF Biorepository in the United States and Canada
Promote consensus-based collaboration
Enable multiple investigation sites
Facilitate clinical studies and accelerate industry-sponsored clinical trials

Partners

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LabCorp

Supports CIRCLES study sites and manages biospecimen storage

University of Utah Data Coordinating Center (DCC)

Clinical database for biospecimen and XNAT imaging support, biostatistics, CIRCLES site support with Clinical Research Coordinator training

Fourteen CIRCLES IRB-approved sites currently enrolling patients and controls in the US and Canada

Cedars-Sinai Medical Center

PI: Nancy Sicotte, M.D.

Cleveland Clinic

PI: Sarah Planchon Pope, Ph.D.

Co-I: Jeffrey Cohen, M.D.

Columbia University Medical Center

PI: Claire Riley, M.D.

Icahn School of Medicine at Mount Sinai

PI: Ilana Katz Sand, M.D.

Johns Hopkins

PI: Michael Levy, M.D., Ph.D.

Massachusetts General Hospital/Brigham and Women’s Hospital

PIs: Tanuja Chitnis, M.D. & Eric Klawiter, M.D.

NYU Langone Medical Center

PI: Ilya Kister, M.D.

Shepherd Center

PI: Ben Thrower, M.D.

Stanford University

PI: May Han, M.D.

Swedish Medical Center

PI: Pavle Repovic, M.D.

University British Columbia, Canada

PI: Anthony Traboulsee, M.D.

University of Colorado Denver

PI: Jeffrey Bennett, M.D.

University of Miami

PI: Leticia Tornes, M.D.

University of Southern California

PI: Lilyana Amezcua, M.D.

Weill Cornell Medical Center/New York-Presbyterian

PI: Nancy Nealon, M.D.

To be a part of CIRCLES, visit the Blood Bank.

ICC – International Clinical Consortium

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Commitment

The Guthy-Jackson Charitable Foundation (GJCF) accelerates breakthrough advances that benefit NMO patients. Our International Clinical Consortium (GJCF-ICC) consists of thought leaders in over 65 institutions engaged in translational research and who practice medicine focused on Neuromyelitis Optica (NMO). These resources are coordinated by the GJCF to promote NMO research and facilitate industry-sponsored trials. GJCF is committed to improving prevention, diagnosis and treatment of NMO by engaging stakeholders through shared values of integrity and transparency.

Mission

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To promote the discovery, development and delivery of improved medicines, therapeutic strategies and diagnostic tools to ultimately cure NMO.

Our mission is realized through scientific, clinical, and educational programs focusing on the NMO patient and advocate community, NIH and regulatory agencies, and industry partners, as integrated through the GJCF-ICC.

Objectives

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The core objective of the GJCF-ICC is to accelerate clinical breakthroughs for NMO. The GJCF-ICC facilitates research. An important goal is to provide patients access to appropriate industry-sponsored studies. The GJCF-ICC supports clinical studies by promoting standardized collection, processing, storing, and distribution of biospecimens, clinical datasets, and related resources to researchers dedicated to solving NMO.

Value-added objectives include:

1: responsible sharing of resources among NMO researchers;

2: identifying epidemiologic factors that contribute to NMO and related diseases;

3: enhancing awareness of NMO and similar autoimmune diseases;

4: standardization of specimen collection; and

5: building global consensus on diagnostic criteria and best clinical practices for NMO/NMOSD.

Scope

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The GJCF-ICC focuses on the implementation of an efficient infrastructure to support mission critical research and industry-sponsored clinical trials.

Enabling Clinical Trials

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The GJCF-ICC is focused on the implementation of an efficient infrastructure to support the most meaningful clinical research and industry-sponsored clinical trials.

Standardized Clinical Studies Infrastructure

Standardized infrastructure is important to efficient performance and interpretation of clinical studies. Common Data Elements (CDEs) and Case Report Forms (CRFs), Standard Operating Procedures (SOPs), and Informed Consent developed through GJCF-ICC consensus harmonize the collection and organization of clinical biospecimens and data to promote their most meaningful translational impact. The goal is to reach global consensus on therapeutic candidates and clinical studies.

Coordinate Mutual Interests of Stakeholders

In rare diseases such as NMO, the key to successful clinical trials is the optimization access of patients to study participation opportunities. The GJCF-ICC works in stride with organizations (industry, regulatory agencies, NIH), and individuals including clinicians and researchers, and of course NMO patients to meet the challenges of clinical studies. Additionally, the GJCF-ICC is designed to accommodate a growing international network to streamline global collaboration and promote efficient administration in the areas of Ethics Committee (EC) or Institutional Review Board (IRB) approvals. The present network includes North America, South America, Europe and Asia-Pacific.

IPND – International Panel for Neuromyelitis Optica Diagnosis

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The IPND was comprised of the following expert members, each of whom contributed effort within one or more panel subgroups and tasks throughout the process. The Guthy-Jackson Charitable Foundation team coordinated and facilitated the IPND in this important

Members

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Brenda Banwell, MD, FRCP(C)

Children’s Hospital of Philadelphia

Jeffrey Bennett, MD, PhD

University of Colorado Denver

Philippe Cabre, MD

Centre Hospitalier Universitaire de Fort de France, (Martinique)

William Carroll, MD

Sir Charles Gairdner Hospital (Australia)

Tanuja Chitnis, MD

Massachusetts General Hospital

Jerome de Seze, MD

Strasbourg University (France)

Kazuo Fujihara, MD

Tohoku University Graduate School of Medicine (Japan)

Benjamin Greenberg, MD

UT Southwestern Medical Center

Anu Jacob, MD

The Walton Centre (United Kingdom)

Sven Jarius, MD

University Hospital Heidelberg (Germany)

Marco Lana-Peixoto, MD, PhD

Federal University of Minas Gerais Medical School (Brazil)

Michael Levy, MD, PhD

Johns Hopkins University

Jack Simon, MD

Portland VA Medical Center and Oregon Health and Sciences University

Silvia Tenembaum, MD

National Pediatric Hospital Dr. Juan P. Garrahan (Argentina)

Anthony Traboulsee, MD

University of British Columbia (Canada)

Patrick Waters, PhD

University of Oxford (United Kingdom)

Brian Weinshenker, MD, FRCP(C)

Mayo Clinic (Rochester, MN)

Dean Wingerchuk, MD, FRCP(C)

Mayo Clinic (Scottsdale, AZ)

Special Projects & Programs

Special Projects & Programs

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