Nutritional and Metabolic DiseasesNPSNCT03272646
Prognostic Performance of the Naples Prognostic Score
An observational study of Nutritional and Metabolic Diseases and Oncologic Disorders, run by University of Campania Luigi Vanvitelli.
Trial summary
To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer patients undergoing surgery Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutritional and Metabolic Diseases, Oncologic Disorders
- What is being tested?
- surgery
- Type of treatment
- Surgery or procedure
- How many people
- 477 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 30 Jun 2017
- How long will I take part?
- 17 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with proven gastric adenocarcinoma undergoing surgery.
Who may be able to join
- all patients undergoing surgery at our institution for proven gastric adenocarcinoma will be enrolled in the present study
Who cannot join
- 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.
About this study
Official title: The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery
To investigate the prognostic performance of the Naples Prognostic Score in gastric cancer patients undergoing surgery
Read the 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.
- Being tested
- surgery
- Keywords
- Gastric Cancer
- Medical subject headings
- Nutritional and Metabolic Diseases, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgeryProcedure or surgery
Also called radical surgery
gastric resection or total gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Group 1 or NPS = 0 | Patients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios. Receives: Procedure: surgery | |
| Group 2 or NPS >0 and < 3 | Patients undergoing surgery with NPS between 1 or 2 Receives: Procedure: surgery | |
| Group 3 or NPS > 2 | Patients undergoing surgery with three or four alterations Receives: Procedure: surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start1 Jan 2000
- Primary completion31 Dec 2015
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 477 participants (actual)
- Target duration
- 17 Years
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gennaro Galizia, University of Campania Luigi Vanvitelli
- Investigators
- Gennaro Galizia, MD, Principal investigator, University of Campania 'Luigi Vanvitelli'
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272646
- Sponsor's protocol ID
- UNI Naples Vanvitelli
- Acronym
- NPS
- Status last verified
- Sep 2017
- First submitted
- 1 Sep 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be made available by contacting the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Naples Prognostic Score in Gastric Cancer Patients Undergoing Surgery
- ClinicalTrials.gov ID
- NCT03272646
- Acronym / sponsor ID
- NPS / UNI Naples Vanvitelli
- Keywords
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 or NPS = 0 | – | Procedure: surgeryPatients undergoing surgery without alterations of the albumin and cholesterol levels, with normal NLR and LMR ratios. |
| Group 2 or NPS >0 and < 3 | – | Procedure: surgeryPatients undergoing surgery with NPS between 1 or 2 |
| Group 3 or NPS > 2 | – | Procedure: surgeryPatients undergoing surgery with three or four alterations |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with proven gastric adenocarcinoma undergoing surgery.
Key inclusion criteria (1 listed)
- all patients undergoing surgery at our institution for proven gastric adenocarcinoma will be enrolled in the present study
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgeryAlso: radical surgerygastric resection or total gastrectomy | Procedure or surgery | Group 1 or NPS = 0, Group 2 or NPS >0 and < 3, Group 3 or NPS > 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Individual participant dataSharing planned: Yes. All data will be made available by contacting the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gennaro Galizia, MD principal investigator
University of Campania 'Luigi Vanvitelli'
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional and Metabolic Diseases and Oncologic Disorders, run by University of Campania Luigi Vanvitelli.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic performance of NPS. (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.