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Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

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ClinicalTrials.gov Identifier: NCT03141021
Recruitment Status : Recruiting
First Posted : May 4, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date April 13, 2017
First Posted Date May 4, 2017
Last Update Posted Date November 20, 2018
Actual Study Start Date April 28, 2017
Estimated Primary Completion Date April 28, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 3, 2017)
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03141021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
Official Title Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
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.
Sampling Method Non-Probability Sample
Study Population The oncology clinic of each participating institution
Condition Malignant Peripheral Nerve Sheath Tumors
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 3, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 28, 2027
Estimated Primary Completion Date April 28, 2027   (Final data collection date for primary outcome measure)
Eligibility 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).

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Angela Hirbe, M.D., Ph.D. (314) 362-8965 hirbea@wustl.edu
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03141021
Other Study ID Numbers 201702006
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor Washington University School of Medicine
Collaborators Not Provided
Investigators
Principal Investigator: Angela Hirbe, M.D., Ph.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date November 2018