NCT03534778

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

3 years

First QC Date

May 11, 2018

Last Update Submit

April 17, 2019

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • Optimal cut-off value for 5 year Overall Survival

    5 years

Study Arms (1)

patients undergoing neck dissection

all patients undergoing neck dissection

Diagnostic Test: Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)

Interventions

Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)DIAGNOSTIC_TEST

LNY and LNR will be examined after neck dissection

patients undergoing neck dissection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients affected by oral or oropharyngeal squamous cell carcinoma who undergo upfront surgery and neck dissection

You may qualify if:

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

You may not qualify if:

  • patients affected by other cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oreste Iocca

Milan, MI, 20138, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30723839DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Lymph Node Ratio

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2024

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations

IT(1)