Prognostic Performance of the Naples Prognostic Score

Completed

• Conditions: Oncologic Disorders; Nutritional and Metabolic Diseases
• Interventions: Procedure: surgery

• Registration Number: NCT03272646
• Lead Sponsor: University of Campania "Luigi Vanvitelli"

Brief Summary

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

• Study Start: 2000-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2017-06-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-01
• Study First Submitted QC: 2017-09-01
• Last Update Submitted: 2017-09-01
• Study First Posted: 2017-09-05
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 3 or NPS > 2	surgery	Patients undergoing surgery with three or four alterations
Group 1 or NPS = 0	surgery	Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.
Group 2 or NPS >0 and < 3	surgery	Patients undergoing surgery with NPS between 1 or 2

Primary Outcome Measures

Name	Time	Method
Prognostic performance of NPS.	through study completion, an average of 1 year	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.