Prognostic Performance of the Naples Prognostic Score (NPS)

The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery

To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer patients undergoing surgery

Study Overview

• Status: Completed
• Conditions: Oncologic Disorders; Nutritional and Metabolic Diseases
• Intervention / Treatment: Procedure: surgery

Detailed Description

The outcome of oncological patients is related not only to the tumor status but also to the host. Particularly the patient's immune and nutritional status have been recently associated with short- and long-term outcome in gastric and other cancers. In addition, there is growing evidence that systemic inflammation plays a crucial role in the carcinogenesis and progression of gastric cancer. The neutrophil to lymphocyte ratio (NLR), and, more recently, the lymphocyte to monocyte ratio (LMR) have been shown to be independently correlated with prognosis in patients with gastric cancer who underwent surgery, and preoperative albumin and cholesterol levels seem to be adequate mirrors of the nutritional status of the host.

The investigators have already demonstrated that a new scoring system, which they called Naples prognostic score (NPS), based on a composite score of albumin and cholesterol concentrations, along with NLR and LMR is a simple tool strongly associated with long-term outcome in patients undergoing surgery for colorectal cancer.

The aim of this study is to assess the correlation between the NPS and clinicopathological characteristics, postoperative complication rate and long-term outcome in patients undergoing surgery for gastric cancer. Furthermore, the new prognostic scoring system will be compared with previously developed ones and the current TNM staging system to evaluate its performance.

All patients who underwent surgery for proven gastric adenocarcinoma at the Division of Surgical Oncology of the Gastrointestinal Tract of the University of Campania (Naples, Italy), from January 2000 to December 2015 will be enrolled in the present study.

• Study Type: Observational
• Enrollment (Actual): 477

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with proven gastric adenocarcinoma undergoing surgery.

Description

Inclusion Criteria:

• all patients undergoing surgery at our institution for proven gastric adenocarcinoma will be enrolled in the present study

Exclusion Criteria:

• Patients with lower esophageal adenocarcinoma or cancer crossing the esophagogastric junction with its epicenter in the proximal 2 cm of stomach, which were taken apart from stomach cancers in the last two AJCC cancer staging editions, will be excluded.
• Patients with ongoing infections, concomitant immune-mediated diseases, or on drugs capable of affecting neutrophil and/or lymphocyte counts (e.g., steroids, immunosuppressants, etc.) will be excluded from the study.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1 or NPS = 0; Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.	Procedure: surgery; gastric resection or total gastrectomy; Other Names: radical surgery
Group 2 or NPS >0 and < 3; Patients undergoing surgery with NPS between 1 or 2	Procedure: surgery; gastric resection or total gastrectomy; Other Names: radical surgery
Group 3 or NPS > 2; Patients undergoing surgery with three or four alterations	Procedure: surgery; gastric resection or total gastrectomy; Other Names: radical surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic performance of NPS.	Corrlation between preoperative NPS and outcome (i.e. overall survival in all patients, and disease-free survival in radically resected patients). The prognostic performance of NPS will be compared to that of the prognostic nutritional index (PNI), the controlling nutritional status (CONUT) score, the systemic inflammation score (SIS), and the TNM staging system.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University of Campania "Luigi Vanvitelli"
• Investigators: Principal Investigator: Gennaro Galizia, MD, University of Campania 'Luigi Vanvitelli'

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2000
• Primary Completion (ACTUAL): December 31, 2015
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 1, 2017
• First Submitted That Met QC Criteria: September 1, 2017
• First Posted (ACTUAL): September 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2017
• Last Update Submitted That Met QC Criteria: September 1, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Gastric Cancer
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: UNI Naples Vanvitelli

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be made available by contacting the principal investigator.
• IPD Sharing Time Frame: at the end of the study
• IPD Sharing Access Criteria: gennaro.galizia@unicampania.it
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No