Prognostic Performance of the Naples Prognostic Score

Nutritional and Metabolic Diseases Clinical Trial

— NPS  

Official title:

The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03272646
• Other study ID #: UNI Naples Vanvitelli
• Status: Completed
• Phase: N/A
• First received: September 1, 2017
• Last updated: September 1, 2017
• Start date: January 1, 2000
• Est. completion date: June 30, 2017

Study information

• Verified date: September 2017
• Source: University of Campania "Luigi Vanvitelli"
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 477
• Est. completion date: June 30, 2017
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Nutritional and Metabolic Diseases
• Oncologic Disorders

Intervention

Procedure:
• surgery
gastric resection or total gastrectomy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Campania "Luigi Vanvitelli"

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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