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NCT03534778 Clinical Trial

Prognostic Significance of Lymph Node Yield and Lymph Node Ratio Prospective Observational Study

Head and Neck Cancer Clinical Trial

Official title:
Prognostic Significance of Lymph Node Yield and Lymph Node Ratio in Patients Affected by Squamous Cell Carcinoma of the Oral Cavity, Hypopharynx and Larynx: a Prospective, Multicenter Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03534778
Other study ID # LNYLNR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 1, 2024

Study information
Verified date April 2019
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

It is still unclear if Lymph Node Yield (LNY) and Lymph Node Ratio (LNR) may have a prognostic role in patients affected by carcinoma of the oral cavity and the oropharynx. Only retrospective studies are available. For this reason, this prospective, multi center, observational study should provide indications in this regard. Proper stratification by patients characteristics will allow to understand if LNY and LNR may enter in the future TNM staging system

Description:

Lymph node involvement is a fundamental prognostic factor in head and neck squamous cell carcinoma (SCC). Lymph node yield (LNY), which is the number of lymph nodes retrieved after neck dissection, and lymph node ratio (LNR), which is the ratio of positive lymph nodes out of the total removed, are measurable indicators that may have the potential to be used as prognostic factors. The present study is designed to define the exact role of LNY and LNR regarding the overall and specific survival of patients affected by oral cavity and oropharyngeal SCC.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 350
Est. completion date January 1, 2024
Est. primary completion date January 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients affected by oral cavity, oropharynx, larynx squamous cell carcinoma

Exclusion Criteria:

- patients affected by other cancers

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)
LNY and LNR will be examined after neck dissection

Locations
Country Name City State
Italy Oreste Iocca Milano MI

Sponsors (1)
Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Optimal cut-off value for 5 year Overall Survival 5 years
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