Prognostic Significance of Lymph Node Yield and Lymph Nod... | NCT03534778

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

NCT03534778

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Apr 19, 2019Actual

Enrollment

350Estimated

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

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

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2022Estimated

Completion Date

Jan 1, 2024Estimated

First Submitted Date

May 11, 2018

First Submission Date that Met QC Criteria

May 22, 2018

First Posted Date

May 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2019

Last Update Posted Date

Apr 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oreste Iocca, M.D., D.D.S., Researcher, Istituto Clinico HumanitasPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

350Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients undergoing neck dissection		all patients undergoing neck dissection	Diagnostic Test: Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)	Diagnostic Test	LNY and LNR will be examined after neck dissection	patients undergoing neck dissection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optimal cut-off value for 5 year Overall Survival		5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients affected by other cancers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oreste Iocca	Recruiting	Milan	MI	20138	Italy

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30723839	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures