Tumor of Peripheral NerveNCT05735548
Tumors of the Peripheral Nervous System
An observational study of Tumor of Peripheral Nerve, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The goal of this observational study is to individuate tumors' and patients' features influencing the outcome after surgical tumor removal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor of Peripheral Nerve
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with confirmed histology of peripheral nerve tumor, operated at our hospital during the 10 years before the study started.
Who may be able to join
- ≥ 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
Who cannot join
- < 18 y.o.
- neurosurgical treatment because other causes (chronic entrapment syndromes, acute nerve lesion)
- denied consent to study participation
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168
About this study
Official title: 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.
Read the 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.
- Conditions
- Tumor of Peripheral Nerve
- Keywords
- outcome, neurosurgery
- Medical subject headings
- Peripheral Nervous System Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
oncological outcome
number of patients with tumor relapses
Measured: 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).
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Jul 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor of Peripheral NerveStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735548
- Sponsor's protocol ID
- ID 3787
- Status last verified
- Jan 2023
- First submitted
- 31 Jan 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Tumors of the Peripheral Nervous System
- ClinicalTrials.gov ID
- NCT05735548
- Acronym / sponsor ID
- ID 3787
- Conditions
- Tumor of Peripheral Nerve
- Keywords
- outcome, neurosurgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with confirmed histology of peripheral nerve tumor, operated at our hospital during the 10 years before the study started.
Key inclusion criteria (3 listed)
- ≥ 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
Key exclusion criteria (3 listed)
- < 18 y.o.
- neurosurgical treatment because other causes (chronic entrapment syndromes, acute nerve lesion)
- denied consent to study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
oncological outcome
Time frame: through study completion, an average of 3 years
number of patients with tumor relapses
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor of Peripheral Nerve, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oncological outcome (time frame: through study completion, an average of 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.