Prognostic Values of Inflammation-based Indices in Gastric Cancer

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Gastrectomy

• Registration Number: NCT05075421
• Lead Sponsor: Gulhane Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2012-01-01
• Study First Submitted: 2021-10-02
• Study First Submitted QC: 2021-10-02
• Study First Posted: 2021-10-12
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2 (normal marker)	Gastrectomy	Patients with normal value of serum markers
Group 1 (high marker)	Gastrectomy	Patients with elevated serum markers

Primary Outcome Measures

Name	Time	Method
5-year survival rates	5 years	The primary clinical outcome of interest is 5-year survival rates.

Trial Locations

Locations (1)

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey