Evidence map›Paper›PMID 30723839›Full record

ArticleContemporary clinical trials communications2019

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.

Oreste Iocca, Alessio Farcomeni, Armando De Virgilio, Pasquale Di Maio, Paweł Golusinski, Luca Malvezzi, Raul Pellini, Wojciech Golusinski, Christopher H Rassekh, Giuseppe Spriano

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03534778 (Prognostic Significance of Lymph Node Yield and Lymph Node Ratio in Patients Affected by Squamous Cell Carcinoma of the Oral Cavity, Hypopharynx and Larynx), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03534778 unknown statusnot on this map

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

TypeobservationalSponsorUniversity of Roma La SapienzaRan2019 to 2024Enrolled350ConditionsHead and Neck CancerArmsLymph Node Yield (LNY) and Lymph Node Ratio (LNR)
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Clinicopathological Characteristics, Prognostic Factors, and Treatment Outcomes of Patients with Oral Tongue Squamous Cell Carcinoma Treated with Glossectomy: A Tertiary Oncology Center Experience.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024
    Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Lymph nodes in health and disease - A pathologist's perspective.Journal of oral and maxillofacial pathology : JOMFP
    Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

Oreste IoccaDepartment of Otolaryngology- Head and Neck Surgery, Humanitas Clinical and Research Center, Rozzano, Milano, Italy.
Alessio FarcomeniDepartment of Public Health and Infectious Diseases Sapienza - University of Rome, Rome, Italy.
Armando De VirgilioDepartment of Otolaryngology- Head and Neck Surgery, Humanitas Clinical and Research Center, Rozzano, Milano, Italy.
Pasquale Di MaioSection of Otolaryngology and Neck Surgery, Dept. of Surgical and Biomedical Sciences, University of Perugia, Perugia, Italy.
Paweł GolusinskiDepartment of Head and Neck Surgery, Poznan University of Medical Sciences, The Greater Poland Cancer Centre, Poznan, Poland.
Luca MalvezziDepartment of Otolaryngology- Head and Neck Surgery, Humanitas Clinical and Research Center, Rozzano, Milano, Italy.
Raul PelliniDepartment of Otolaryngology- Head and Neck Surgery, Regina Elena National Cancer Institute, IRCCS, Rome, Italy.
Wojciech GolusinskiDepartment of Head and Neck Surgery, Poznan University of Medical Sciences, The Greater Poland Cancer Centre, Poznan, Poland.
Christopher H RassekhDepartment of Otorhinolaryngology - Head and Neck Surgery, University of Pennsylvania Health System, Philadelphia, PA, USA.
Giuseppe SprianoDepartment of Otolaryngology- Head and Neck Surgery, Humanitas Clinical and Research Center, Rozzano, Milano, Italy.
Humanitas University · ITPoznan University of Medical Sciences · PLDepartment of Public Health · MMIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversity of Pennsylvania Health System · USUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLymph 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. It has been registered on clinicaltrials.gov database (NCT03534778).

methodsThis 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.

Identifiers

PMID30723839
PMCPMC6353728
OpenAlexW2910337422

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.