- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05735548
Tumors of the Peripheral Nervous System
Prognostic Factors in Tumors of the Peripheral Nervous System
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Rome, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
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number of patients with tumor relapses
|
through study completion, an average of 3 years
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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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ID 3787
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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