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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"

Tracking Information
First Submitted Date September 1, 2017
First Posted Date September 5, 2017
Last Update Posted Date September 5, 2017
Actual Study Start Date January 1, 2000
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 1, 2017)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Performance of the Naples Prognostic Score
Official Title The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 17 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with proven gastric adenocarcinoma undergoing surgery.
Condition
  • Nutritional and Metabolic Diseases
  • Oncologic Disorders
Intervention Procedure: surgery
gastric resection or total gastrectomy
Other Name: radical surgery
Study Groups/Cohorts
  • Group 1 or NPS = 0
    Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.
    Intervention: Procedure: surgery
  • Group 2 or NPS >0 and < 3
    Patients undergoing surgery with NPS between 1 or 2
    Intervention: Procedure: surgery
  • Group 3 or NPS > 2
    Patients undergoing surgery with three or four alterations
    Intervention: Procedure: surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 1, 2017)
477
Original Actual Enrollment Same as current
Actual Study Completion Date June 30, 2017
Actual Primary Completion Date December 31, 2015   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03272646
Other Study ID Numbers UNI Naples Vanvitelli
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: at the end of the study
Access Criteria: gennaro.galizia@unicampania.it
Responsible Party Gennaro Galizia, University of Campania "Luigi Vanvitelli"
Study Sponsor University of Campania "Luigi Vanvitelli"
Collaborators Not Provided
Investigators
Principal Investigator: Gennaro Galizia, MD University of Campania 'Luigi Vanvitelli'
PRS Account University of Campania "Luigi Vanvitelli"
Verification Date September 2017