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Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

This study is currently recruiting participants.
Verified May 2017 by Washington University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03141021
First Posted: May 4, 2017
Last Update Posted: May 4, 2017
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.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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
Malignant Peripheral Nerve Sheath Tumors

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

Estimated Enrollment: 1000
Actual Study Start Date: April 28, 2017
Estimated Study Completion Date: April 28, 2027
Estimated Primary Completion Date: April 28, 2027 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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).

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

Locations
United States, Maryland
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, 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.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Angela Hirbe, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03141021     History of Changes
Other Study ID Numbers: 201702006
First Submitted: April 13, 2017
First Posted: May 4, 2017
Last Update Posted: May 4, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neurofibroma
Neoplasms by Histologic Type
Nerve Sheath Neoplasms
Neurilemmoma
Neurofibrosarcoma
Neoplasms, Nerve Tissue
Neoplasms
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroma
Fibrosarcoma
Neoplasms, Fibrous Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Sarcoma