Prognostic Performance of the Naples Prognostic Score

NCT03272646 | Completed DMC

• 1 other identifier: UNI Naples Vanvitelli
• Study Type: observational
• Target: 477
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nutritional and Metabolic Diseases; Oncologic Disorders

Keywords

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Group 1 or NPS = 0

Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.

Procedure: surgery

Group 2 or NPS >0 and < 3

Patients undergoing surgery with NPS between 1 or 2

Procedure: surgery

Group 3 or NPS > 2

Patients undergoing surgery with three or four alterations

Procedure: surgery

Interventions

surgery PROCEDURE

gastric resection or total gastrectomy

Also known as: radical surgery

Group 1 or NPS = 0; Group 2 or NPS >0 and < 3; Group 3 or NPS > 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with proven gastric adenocarcinoma undergoing surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

MeSH Terms

Conditions

Nutritional and Metabolic Diseases; Stomach Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Gennaro Galizia, MD

  University of Campania 'Luigi Vanvitelli'

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Surgery

Study Record Dates

• First Submitted: September 1, 2017
• First Posted: September 5, 2017
• Study Start: January 1, 2000
• Primary Completion: December 31, 2015
• Study Completion: June 30, 2017
• Last Updated: September 5, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: at the end of the study
• Access Criteria: gennaro.galizia@unicampania.it