Oral Cavity Squamous Cell CarcinomaNCT03727594
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
An observational study of Oral Cavity Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Oral Cavity Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Jan 2021
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.
Who may be able to join
- 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)
Who cannot join
- rejected informed consent
- patients not fit to surgery (according to the general health condition and the clinical tumor stage)
- pregnant women
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
University Hospital of Ferrara
Ferrara, 44124
Nicola Malagutti, MD, +393339011406, nicolamalagutti@gmail.com
About this study
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.
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy
Measured: 5 years
Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study startJan 2016
- Primary completionJan 2020 (estimated)
- Study completionJan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Cavity Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Malagutti, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727594
- Sponsor's protocol ID
- 151099
- Status last verified
- Oct 2018
- First submitted
- 8 Jul 2018
- Last updated
- 1 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03727594
- Acronym / sponsor ID
- 151099
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2021 (estimated)
- First posted
- 1 Nov 2018 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- rejected informed consent
- patients not fit to surgery (according to the general health condition and the clinical tumor stage)
- pregnant women
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
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy
Time frame: 5 years
Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins
Time frame: 5 years
Overall survival
Time frame: 5 years
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.
Disease-free survival
Time frame: 5 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
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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.
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 Oral Cavity Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by University Hospital of Ferrara 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 1 Nov 2018. 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?
Contact Nicola Malagutti, MD (+393339011406, nicolamalagutti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy (time frame: 5 years). The study lists 4 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 1 Nov 2018.