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Prognostic Performance of the Naples Prognostic Score

The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03272646
Acronym
NPS
Enrollment
477
Registered
2017-09-05
Start date
2000-01-01
Completion date
2017-06-30
Last updated
2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutritional and Metabolic Diseases, Oncologic Disorders

Keywords

Gastric Cancer

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.

Interventions

PROCEDUREsurgery

gastric resection or total gastrectomy

Sponsors

University of Campania Luigi Vanvitelli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Prognostic performance of NPS.through study completion, an average of 1 yearCorrlation 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026