Multi-Institutional Registry for Malignant Peripheral Nerve Sheath Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Malignant Peripheral Nerve Sheath Tumors. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada, India, Japan, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Histologic characteristics of malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
- Immunohistochemical characteristics of malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
- Molecular characteristics of malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
- Radiographic characteristics of malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
- Treatment given to patients with malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
- Future genomic characterization of malignant peripheral nerve sheath tumor (MPNST) [Time frame: 10 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Moffitt Cancer Center — Tampa
- Johns Hopkins — Baltimore
- National Institutes of Health (NIH) — Bethesda
- Dana Farber Cancer Institute — Boston
- University of Minnesota — Minneapolis
- Washington University School of Medicine — St Louis
- Memorial Sloan Kettering Cancer Center — New York
- Lifespan — Providence
- … and 1 more center
Canada · 1 center
- Mount Sinai — Toronto
India · 1 center
- Global Gene Corporation — Mumbai
Japan · 1 center
- Nagoya University Hospital — Nagoya
United Kingdom · 1 center
- Royal National Orthopedic Hospital — London
Identifiers
NCT: NCT03141021 · 201702006