Tumors of the Peripheral Nervous System

February 9, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Prognostic Factors in Tumors of the Peripheral Nervous System

The goal of this observational study is to individuate tumors' and patients' features influencing the outcome after surgical tumor removal.

Study Overview

Status

Active, not recruiting

Conditions

Tumor of Peripheral Nerve

Detailed Description

Patients operated because of removal of Peripheral Nervous System (PNS) tumor will be recruited accordingly to the inclusion criteria: the aims of the study will be illustrated and the informed consent signed.

All the clinical and neuroradiological perioperative documents of the enrolled patients will be analyzed. As follow-up, thorough neurological exam wil be performed and specific surveys about after surgery social and working life will be administered; neuroradiological imaging will be performed.

Then, the results will be investigated to individuate which factors were related to the outcome.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Rome, Italy, 00168
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with confirmed histology of peripheral nerve tumor, operated at our hospital during the 10 years before the study started.

Description

Inclusion Criteria:

≥ 18 y.o.
neurosurgical removal of peripheral nerve tumor at our University Hospital "Fondazione Policlinico Universitario Agostino Gemelli (FPG)" during the previous 10 years
signed consent to study participation

Exclusion Criteria:

< 18 y.o.
neurosurgical treatment because other causes (chronic entrapment syndromes, acute nerve lesion)
denied consent to study participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oncological outcome Time Frame: through study completion, an average of 3 years	number of patients with tumor relapses	through study completion, an average of 3 years
functional outcome Time Frame: through study completion, an average of 3 years	evaluation of: 1) Motor function accordingly to the "Medical Research Council muscle power scale (MRC); 2) Sensation accordingly to "The Ten Test for Sensation" (TTTS); 3) Pain accordingly to the "Numerical Rating Scale for Pain" (NRS).	through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 30, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

January 31, 2023

First Submitted That Met QC Criteria

February 9, 2023

First Posted (Estimate)

February 20, 2023

Study Record Updates

Last Update Posted (Estimate)