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Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03141021
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
First, the investigators plan to use a retrospective analysis to determine the clinical landscape of neurofibromatosis (NF)1-associated malignant peripheral nerve sheath tumor (MPNST) and precursor lesions (e.g., atypical or nodular plexiform neurofibromas). A worldwide database will be established, collecting, in a standardized manner, histologic, immunohistochemical, molecular, radiographic, treatment, and related clinical data from centers worldwide with expertise in these NF1-related cancers. Although retrospective in nature, the resulting data from this registry may reveal previously unanticipated patterns, similar to the INFACT effort outcome. This registry would then allow the acquisition of data associated with MPNST biospecimens collected under associated banks (frozen or paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic whole-exome or whole-genome sequencing data for aggregate analyses). Second, the investigators plan to co-register patients to institutional banks in order to prospectively collect MPNST samples for analysis. These patients will be consented in order to collect the above information and for banking of tumor tissue and future studies that include genomic characterization of the tumors.

Condition or disease
Malignant Peripheral Nerve Sheath Tumors

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : April 28, 2027
Estimated Study Completion Date : April 28, 2027





Primary Outcome Measures :
  1. Histologic characteristics of malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST

  2. Immunohistochemical characteristics of malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST

  3. Molecular characteristics of malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST

  4. Radiographic characteristics of malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST

  5. Treatment given to patients with malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST

  6. Future genomic characterization of malignant peripheral nerve sheath tumor (MPNST) [ Time Frame: 10 years ]
    -The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST


Biospecimen Retention:   Samples With DNA
Biospecimens collected under associated banks (frozen or paraffin-embedded, germline (or normal tissue DNA) samples, and any previously somatic whole-exome or whole-genome sequencing data for aggregate analyses) and prospectively collect MPNST samples for analysis.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The oncology clinic of each participating institution
Criteria

Inclusion Criteria and Exclusion Criteria:

-Any patient diagnosed with an MPNST is eligible for enrollment to this registry provided s/he consents to participate (or consent form his/her parent or legal guardian is obtained).


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141021


Contacts
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Contact: Angela Hirbe, M.D., Ph.D. (314) 362-8965 hirbea@wustl.edu

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Xia Wang, M.D., Ph.D.    888-663-3488      
Principal Investigator: Xia Wang, M.D., Ph.D.         
United States, Maryland
Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Christine Pratilas, M.D.    410-955-8751      
Principal Investigator: Christine Pratilas, M.D.         
National Institutes of Health (NIH) Not yet recruiting
Bethesda, Maryland, United States, 20892
Contact: Jack F Shern, M.D.    301-402-1444    john.shern@nih.gov   
Principal Investigator: Jack F Shern, M.D.         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: David Miller, M.D., Ph.D.    617-355-8221      
Principal Investigator: David Miller, M.D., Ph.D.         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Christopher Moertel, M.D.    612-626-2778      
Principal Investigator: Christopher Moertel, M.D.         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Angela Hirbe, M.D., Ph.D.    314-362-8965    hirbea@wustl.edu   
Principal Investigator: Angela Hirbe, M.D., Ph.D.         
Sub-Investigator: David Gutmann, M.D., Ph.D.         
Sub-Investigator: Sonika Dahiya, M.D., MBBS         
Sub-Investigator: Brian Van Tine, M.D., Ph.D.         
Sub-Investigator: Peter Oppelt, M.D.         
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10065
Contact: Ping Chi, M.D., Ph.D.    646-888-4166      
Principal Investigator: Ping Chi, M.D., Ph.D.         
United States, Rhode Island
Lifespan Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jesse Hart, DO    401-606-2082      
Principal Investigator: Jesse Hart, DO         
Canada, Ontario
Mount Sinai Recruiting
Toronto, Ontario, Canada, M5T 3L9
Contact: Jay Wunder, M.D.    416-586-5995    jay.wunder@sinaihealthsystem.ca   
Principal Investigator: Jay Wunder, M.D.         
India
Global Gene Corporation Recruiting
Mumbai, India
Contact: Neeta Sarkar Roy, Ph.D.         
Principal Investigator: Neeta Sarkar Roy, Ph.D.         
United Kingdom
Royal National Orthopedic Hospital Recruiting
London, United Kingdom
Contact: Joanne McDonald         
Principal Investigator: Joanne McDonald         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Angela Hirbe, M.D., Ph.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03141021    
Other Study ID Numbers: 201702006
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nerve Sheath Neoplasms
Neurofibrosarcoma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma
Neurofibroma