Clinical trial NCT03141021: Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
Official title: Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Peripheral Nerve Sheath Tumors
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Boston's Children Hospital
First posted: 2017-05-04
Enrollment: 1050
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The oncology clinic of each participating institution

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.


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 or legally authorized representative is obtained).

Primary outcomes:
measure: Histologic characteristics of malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
measure: Immunohistochemical characteristics of malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
measure: Molecular characteristics of malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
measure: Radiographic characteristics of malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
measure: Treatment given to patients with malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
measure: Future genomic characterization of malignant peripheral nerve sheath tumor (MPNST)
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Bethesda
country: United States
facility: National Institutes of Health (NIH)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Providence
country: United States
facility: Lifespan
state: Rhode Island
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Toronto
country: Canada
facility: Mount Sinai
state: Ontario
city: Mumbai
country: India
facility: Global Gene Corporation
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Showa Ward
city: London
country: United Kingdom
facility: Royal National Orthopedic Hospital
Study officials:
affiliation: Washington University School of Medicine
name: Angela Hirbe, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: