- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684835
Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors
January 12, 2023 updated by: Chi Chen Huang, National Cheng-Kung University Hospital
Radiographic Prediction of the Nerve Origin of Neck Peripheral Nerve Sheath Tumors: Retrospective Cohort Study
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors.
This study is a retrospective cohort aimed to predict the nerve origin of neck peripheral nerve sheath tumors.
Accurate preoperative identification of the nerve origin can improve surgical outcomes and patient counseling
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Postoperative nerve palsy is a major complication following resection of neck peripheral nerve sheath tumors (PNSTs).
Accurate preoperative identification of the nerve origin (NO) can improve surgical outcomes and patient counseling.
This study aims to predict the NO of neck PNSTs with radiographic analysis.
This study is a retrospective cohort analysis.
Radiographic parameters will be reviewed and the sensitivity, specificity, accuracy of NO prediction will be evaluated.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chi-Chen Huang, MD
- Phone Number: 258821 06-2353535
- Email: charles042085@hotmail.com
Study Locations
-
-
-
Taipei, Taiwan, 704
- Recruiting
- National Cheng-Kung University Hospital
-
Contact:
- Chi-Chen Huang, MD
- Phone Number: 258821 06-2353535
- Email: charles042085@hotmail.com
-
-
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
20 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with an intraoperatively confirmed neck PNST and NO between January 2008 and December 2022 who underwent surgical excision of neck PNST with anterior approach, excluding patients with previous anterior neck surgery, malignant disease, prior neck radiation, and undetermined intraoperative NO.
Description
Inclusion Criteria:
- Patients with clinical diagnosis of neck peripheral nerve sheath tumors.
- Patients received surgery January 2008 and December 2022.
- The nerve origin of peripheral nerve sheath tumor must be intraoperatively confirmed.
Exclusion Criteria:
- Previous anterior neck surgery.
- Malignant disease.
- Prior neck radiation.
- Undetermined intraoperative nerve origin.
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
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Vagus nerve tumor group
patients with neck peripheral nerve sheath tumors originating from the vagus nerve
|
All patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO.
Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors.
The NO was confirmed intraoperatively.
Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers.
|
|
Sympathetic nerve tumor group
patients with neck peripheral nerve sheath tumors originating from the sympathetic nerve
|
All patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO.
Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors.
The NO was confirmed intraoperatively.
Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers.
|
|
Cervical spinal nerve tumor group
patients with neck peripheral nerve sheath tumors originating from the cervical spinal nerve
|
All patients underwent surgery under general anesthesia and intraoperative neuromonitoring according to the preoperatively predicted NO.
Using an anterior cervical approach, the tumor was delineated after identifying the relationships among the great vessels, nerves, and tumors.
The NO was confirmed intraoperatively.
Sharp dissection was performed meticulously to enucleate the tumor from the NO to preserve most nerve fibers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nerve origin
Time Frame: within 1 month
|
intraoperative identification of the nerve origin of the tumor
|
within 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 1, 2008
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
January 5, 2023
First Submitted That Met QC Criteria
January 5, 2023
First Posted (Actual)
January 13, 2023
Study Record Updates
Last Update Posted (Estimate)
January 16, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neuromuscular Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Peripheral Nervous System Diseases
- Nervous System Neoplasms
- Neuroendocrine Tumors
- Peripheral Nervous System Neoplasms
- Neuroma
- Nerve Sheath Neoplasms
- Neurilemmoma
Other Study ID Numbers
- A-ER-109-209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Peripheral Nerve Sheath Tumors
-
Memorial Sloan Kettering Cancer CenterTaiho Pharmaceuticals, Inc.RecruitingMalignant Peripheral Nerve Sheath Tumors (MPNST)United States
-
Oslo University HospitalMerck Sharp & Dohme LLCTerminatedMalignant Peripheral Nerve Sheath Tumour (MPNST)Norway
-
University of MinnesotaRecruitingPrimary Malignant Peripheral Nerve Sheath TumorsUnited States
-
Sidney Kimmel Comprehensive Cancer Center at Johns...Bristol-Myers Squibb; Congressionally Directed Medical Research Programs; Cancer...CompletedNerve Sheath TumorsUnited States
-
Sarcoma Alliance for Research through CollaborationUnited States Department of Defense; Synta Pharmaceuticals Corp.CompletedSarcoma | Malignant Peripheral Nerve Sheath Tumors (MPNST)United States
-
Ascentage Pharma Group Inc.Merck Sharp & Dohme LLCActive, not recruitingMelanoma | P53 Mutation | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Unresectable or Metastatic Melanoma or Advanced Solid Tumors | MDM2 Gene Mutation | Malignant Peripheral Nerve Sheath Tumors (MPNST)United States, Australia
-
University of Texas Southwestern Medical CenterWithdrawnPeripheral Nerve TumorsUnited States
-
University of FloridaEpizyme, Inc.Active, not recruitingPeripheral Nerve Sheath TumorUnited States
-
Memorial Sloan Kettering Cancer CenterBayerCompletedSarcoma | Leiomyosarcoma | Malignant Peripheral Nerve Sheath Tumor | Synovial SarcomaUnited States
-
Washington University School of MedicineBoston Children's HospitalRecruitingMalignant Peripheral Nerve Sheath TumorsUnited States, Canada, India, Japan, United Kingdom
Clinical Trials on Excision
-
University Hospital Gregorio MarañónHospital del Rio Hortega; Hospital de Leon; University of Navarrra Hospital (Clinica...RecruitingRectal Cancer | Sphincter Ani IncontinenceSpain
-
Marieke GoodijkDutch Cancer SocietyRecruiting
-
Yanhong DengRecruiting
-
University Hospital TuebingenSuspendedCarcinoma, Basal CellGermany
-
University Hospital, BordeauxSanofi; Roche Pharma AGCompleted
-
Zagazig UniversityCompleted
-
Sahlgrenska University Hospital, SwedenSwedish Cancer FoundationCompleted
-
London Health Sciences Centre Research Institute...WithdrawnBreast Fibroadenoma | Lobular Carcinoma in Situ | Atypical Ductal Hyperplasia | Phyllodes Breast Tumor | Atypical Lobular Hyperplasia | Flat Epithelial Atypia | Phyllodes; Fibroadenoma | Radial Scar | Breast Papilloma | Complex Sclerosing Papillary Lesion of the Breast
-
Haruhiko FukudaMinistry of Health, Labour and Welfare, JapanCompleted
-
Karolinska University HospitalUppsala University Hospital; Stockholm South General Hospital; Capio Sankt Görans...Recruiting