Prognostic Significance of Lymph Node Yield and Lymph Node Ratio Prospective Observational Study
NCT ID: NCT03534778
Last Updated: 2019-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
350 participants
OBSERVATIONAL
2019-01-01
2024-01-01
Brief Summary
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Detailed Description
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This is a multicenter study involving tertiary care referral centers in Europe and North America. Patients affected by oral cavity, HPV+ and HPV- oropharyngeal SCC undergoing neck dissection will be consecutively enrolled and followed-up for up to 5 years. Patients and disease characteristic will be properly recorded and centrally analyzed. The primary end-point is to define reliable cut off- values for LNY and LNR which may serve as prognosticators of survival. This will be achieved through the use of ROC curves. Secondary outcomes will be the Overall survival (OS), Disease Specific Survival (DSS), and Progression Free Survival Hazard Ratios (HR) at 2-, 3- and 5 years, which will be evaluated through the Kaplan-Meier method and the difference in survival attested by the log-rank test. Univariate and multivariate analysis will be performed to understand the association of various outcomes with LNY and LNR.
Conditions
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Study Groups
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patients undergoing neck dissection
all patients undergoing neck dissection
Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)
LNY and LNR will be examined after neck dissection
Interventions
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Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)
LNY and LNR will be examined after neck dissection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Oreste Iocca, M.D., D.D.S.
Researcher
Locations
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Oreste Iocca
Milan, MI, Italy
Countries
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Facility Contacts
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References
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Iocca O, Farcomeni A, De Virgilio A, Di Maio P, Golusinski P, Malvezzi L, Pellini R, Golusinski W, Rassekh CH, Spriano G. Prognostic significance of lymph node yield and lymph node ratio in patients affected by squamous cell carcinoma of the oral cavity and oropharynx: Study protocol for a prospective, multicenter, observational study. Contemp Clin Trials Commun. 2019 Jan 14;14:100324. doi: 10.1016/j.conctc.2019.100324. eCollection 2019 Jun.
Other Identifiers
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LNYLNR
Identifier Type: -
Identifier Source: org_study_id
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