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Prognostic Performance of the Naples Prognostic Score (NPS)

U

University of Campania "Luigi Vanvitelli"

Status

Completed

Conditions

Nutritional and Metabolic Diseases
Oncologic Disorders

Treatments

Procedure: surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03272646
UNI Naples Vanvitelli

Details and patient eligibility

About

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

Full 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.

Enrollment

477 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

477 participants in 3 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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