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Prognostic Performance of the Naples Prognostic Score (NPS)

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ClinicalTrials.gov Identifier: NCT03272646
Recruitment Status : Completed
First Posted : September 5, 2017
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Gennaro Galizia, University of Campania "Luigi Vanvitelli"

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

Condition or disease Intervention/treatment
Nutritional and Metabolic Diseases Oncologic Disorders Procedure: 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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 477 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 17 Years
Official Title: The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery
Actual Study Start Date : January 1, 2000
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Group/Cohort Intervention/treatment
Group 1 or NPS = 0
Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.
Procedure: surgery
gastric resection or total gastrectomy
Other Name: radical surgery

Group 2 or NPS >0 and < 3
Patients undergoing surgery with NPS between 1 or 2
Procedure: surgery
gastric resection or total gastrectomy
Other Name: radical surgery

Group 3 or NPS > 2
Patients undergoing surgery with three or four alterations
Procedure: surgery
gastric resection or total gastrectomy
Other Name: radical surgery




Primary Outcome Measures :
  1. Prognostic performance of NPS. [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with proven gastric adenocarcinoma undergoing surgery.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03272646


Sponsors and Collaborators
University of Campania "Luigi Vanvitelli"
Investigators
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Principal Investigator: Gennaro Galizia, MD University of Campania 'Luigi Vanvitelli'

Additional Information:

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Responsible Party: Gennaro Galizia, Full Professor of Surgery, University of Campania "Luigi Vanvitelli"
ClinicalTrials.gov Identifier: NCT03272646     History of Changes
Other Study ID Numbers: UNI Naples Vanvitelli
First Posted: September 5, 2017    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be made available by contacting the principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: at the end of the study
Access Criteria: gennaro.galizia@unicampania.it

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gennaro Galizia, University of Campania "Luigi Vanvitelli":
Gastric Cancer
Additional relevant MeSH terms:
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Metabolic Diseases