Tumors of the Peripheral Nervous System | NCT05735548

Studies
Tumors of the Peripheral Nervous System

NCT05735548

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Unknown status

Last Update Posted

Feb 21, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Tumor of Peripheral Nerve

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Actual

Primary Completion Date

Jun 30, 2024Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Jan 31, 2023

First Submission Date that Met QC Criteria

Feb 9, 2023

First Posted Date

Feb 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2023

Last Update Posted Date

Feb 21, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
oncological outcome	number of patients with tumor relapses	through study completion, an average of 3 years
functional outcome	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli IRCCS		Rome		00168	Italy

Condition Browse Module

MeSH Terms

ID	Term
D010524	Peripheral Nervous System Neoplasms

Ancestor Terms

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided