Clinical trial NCT03272646: Prognostic Performance of the Naples Prognostic Score
Official title: The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional and Metabolic Diseases
Oncologic Disorders
Keywords: Gastric Cancer
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 477
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with proven gastric adenocarcinoma 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.

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.

Primary outcomes:
measure: Prognostic performance of NPS.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Campania 'Luigi Vanvitelli'
name: Gennaro Galizia, MD
role: PRINCIPAL_INVESTIGATOR
References: