An observational study in Nutritional and Metabolic Diseases and Oncologic Disorders, sponsored by University of Campania Luigi Vanvitelli. Completed. Per ClinicalTrials.gov, last updated 2017-09-05.
Sponsored by University of Campania Luigi Vanvitelli · Observational
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To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer patients undergoing surgery
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.
72 studies on the registry are indexed under Nutritional and Metabolic Diseases; 20 are open to participants now.
This study's enrollment of 477 is above the median of 338 across 18 observational studies indexed under Nutritional and Metabolic Diseases.
Browse Nutritional and Metabolic Diseases studies →University of Campania Luigi Vanvitelli is the lead sponsor of 174 studies on the registry; 28 are open to participants now.
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Patients with proven gastric adenocarcinoma undergoing surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios.
Procedure: surgery
Patients undergoing surgery with NPS between 1 or 2
Procedure: surgery
Patients undergoing surgery with three or four alterations
Procedure: surgery
gastric resection or total gastrectomy
Also known as: radical surgery
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.
Time frame: through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: Yes — All data will be made available by contacting the principal investigator.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: at the end of the study
Access criteria: gennaro.galizia@unicampania.it
No publications or documents are linked to this record.
Ran from Jan 2000 to primary completion in Dec 2015, 191 months.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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