Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

Malignant Peripheral Nerve Sheath Tumors Clinical Trial

Official title:

Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03141021
• Other study ID #: 201702006
• Status: Recruiting
• Start date: April 28, 2017
• Est. completion date: April 30, 2053

Study information

• Verified date: November 2023
• Source: Washington University School of Medicine
• Contact: Angela Hirbe, M.D., Ph.D.
• Phone: (314) 362-8965
• Email: hirbea[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: April 30, 2053
• Est. primary completion date: April 30, 2053
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Malignant Peripheral Nerve Sheath Tumors
• Nerve Sheath Neoplasms

Locations

Country	Name	City	State
Canada	Mount Sinai	Toronto	Ontario
India	Global Gene Corporation	Mumbai
United Kingdom	Royal National Orthopedic Hospital	London
United States	Johns Hopkins	Baltimore	Maryland
United States	National Institutes of Health (NIH)	Bethesda	Maryland
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	University of Minnesota	Minneapolis	Minnesota
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Lifespan	Providence	Rhode Island
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Boston's Children Hospital

Countries where clinical trial is conducted

United States,  Canada,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic characteristics of malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years
Primary	Immunohistochemical characteristics of malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years
Primary	Molecular characteristics of malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years
Primary	Radiographic characteristics of malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years
Primary	Treatment given to patients with malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years
Primary	Future genomic characterization of malignant peripheral nerve sheath tumor (MPNST)	-The data collected through this registry will be used to analyze previously unanticipated patterns and prognostic clues about MPNST	10 years

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine