Prognostic Values of Inflammation-based Indices in Gastric Cancer

March 16, 2022 updated by: Suleyman Utku Celik, Gulhane Training and Research Hospital

Comparison of the Prognostic Values of Preoperative Inflammation-based Indices in Patients Undergoing Resection of Gastric Cancer

This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Gastric cancer is one of the most common and deadly cancers worldwide. Based on GLOBOCAN 2018 data, it is the fifth most common malignancy and the third leading cause of cancer deaths, with an estimated 783,000 deaths in 2018. Despite advances in diagnosis and management strategies, outcomes for patients diagnosed with gastric cancer still remain poor and the five-year survival is approximately %20. In addition, there is marked heterogeneity in the duration of survival among patients. Hence, there are increasing research efforts towards the identification of possible predictive clinical, pathological, or biologic factors to determine more accurate patient stratification, which will improve clinical decision-making and possibly contribute to more rational study design and analysis. Systemic inflammation is known to play a crucial role in the pathogenesis, development, and progression of cancer. Preoperative inflammation-based indices, such as the Glasgow prognostic score (GPS), modified Glasgow prognostic score (mGPS), neutrophil-lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR), prognostic index (PI), prognostic nutritional index (PNI), CRP/albumin ratio, systemic inflammation score (SIS), modified systemic inflammation score (mSIS), have been found to have potential prognostic values in various cancer. Previous studies have suggested that several of these scoring systems may have a role in predicting survival in patients with upper gastrointestinal cancer. These scores are all derived from blood tests that are already routinely performed in clinical practice and thus have the potential to offer valuable additional information that may help to guide patient management. This study aims to evaluate the prognostic values of preoperative inflammation-based indices in patients undergoing potentially curative resection of gastric cancer.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06010
        • Gulhane Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients aged ≥ 18 years who underwent a surgical procedure for gastric cancer are included in this study

Description

Inclusion Criteria:

  • Patients over the age of 18 who underwent a surgical procedure for gastric cancer

Exclusion Criteria:

  • Patients < 18 years of age
  • Patients with no routine blood examination before surgery or incomplete medical records
  • Patients followed up less than 3 months
  • Patients with additional malignancy
  • Patients having tumors that invading adjacent organs
  • Patients with adjacent or distant metastasis
  • Patients receiving neoadjuvant therapy (chemo- or radiotherapy)
  • Patients with previous malignancy history
  • Patients with a clinical evidence of infection
  • Patients with a history of preoperative use of anti-inflammatory drugs or immunosuppressive treatment
  • Patients with a history of chronic inflammatory disease or autoimmune disease
  • Patients who underwent emergency surgical resection
  • Patients who have undergone R1/R2 resection or those with positive peripheral margins
  • Patients with missing data on follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1 (high marker)
Patients with elevated serum markers
Procedure: Gastrectomy
Any type of gastrectomy for gastric cancer
Group 2 (normal marker)
Patients with normal value of serum markers
Procedure: Gastrectomy
Any type of gastrectomy for gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
5-year survival rates
Time Frame: 5 years
The primary clinical outcome of interest is 5-year survival rates.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane Training and Research Hospital

Investigators

  • Principal Investigator: Suleyman U Celik, Gulhane Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 2, 2021

First Submitted That Met QC Criteria

October 2, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 16, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gulhane2021-69

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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