Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
1 other identifier
observational
50
1 country
1
Brief Summary
The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 8, 2018
CompletedFirst Posted
Study publicly available on registry
November 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2021
CompletedNovember 1, 2018
October 1, 2018
4 years
July 8, 2018
October 31, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy
5 years
Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins
5 years
Overall survival
Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
5 years
Disease-free survival
Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.
5 years
Eligibility Criteria
Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.
You may qualify if:
- accepted informed consent
- preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma
- patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)
You may not qualify if:
- rejected informed consent
- patients not fit to surgery (according to the general health condition and the clinical tumor stage)
- pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Ferrara
Ferrara, 44124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 8, 2018
First Posted
November 1, 2018
Study Start
January 1, 2016
Primary Completion
January 1, 2020
Study Completion
January 1, 2021
Last Updated
November 1, 2018
Record last verified: 2018-10