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Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT03727594
Recruitment Status : Unknown
Verified October 2018 by Nicola Malagutti, University Hospital of Ferrara.
Recruitment status was:  Recruiting
First Posted : November 1, 2018
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
Nicola Malagutti, University Hospital of Ferrara

Study Description
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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.

Condition or disease
Oral Cavity Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy [ Time Frame: 5 years ]
  2. Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins [ Time Frame: 5 years ]
  3. 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.

  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • rejected informed consent
  • patients not fit to surgery (according to the general health condition and the clinical tumor stage)
  • pregnant women
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727594


Contacts
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Contact: Nicola Malagutti, MD +393339011406 nicolamalagutti@gmail.com

Locations
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Italy
University Hospital of Ferrara Recruiting
Ferrara, Italy, 44124
Contact: Nicola Malagutti, MD    +393339011406    nicolamalagutti@gmail.com   
Sponsors and Collaborators
University Hospital of Ferrara
More Information
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Responsible Party: Nicola Malagutti, Principal Investigator, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT03727594    
Other Study ID Numbers: 151099
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site