Systemic Oxidative Stress Score as a Predictor of Gastric Cancer Survival and Recurrence Risk

Completed

• Conditions: Gastric Cancer

• Registration Number: NCT06337279
• Lead Sponsor: Fujian Medical University

Brief Summary

The Systemic Oxidative Stress Score (SOSS) , a comprehensive score reflecting the oxidative stress conditions in the microenvironment, can independently and effectively predict tumor burden and long-term prognosis in GC patients. Nomograms based on SOSS provide a potential and promising model for risk stratification and guiding the implementation of treatment decisions.

Detailed Description

We retrospectively analyzed the clinical data of gastric cancer patients who underwent radical gastrectomy in three hospitals from January 2009 to June 2020. The data from one hospital were randomly divided into a training cohort and an internal validation cohort in a 7:3 ratio, while the data from the other two centers were used as an external validation cohort. In the training cohort, COX proportional risk models were employed to identify key indicators of SOSS and independent prognostic factors influencing patients' OS and DFS. Subsequently, based on the results of the multifactor COX analysis, two predictive models for OS and DFS were developed. The predictive efficacy, calibration, and clinical utility of the models were evaluated using ROC curves, calibration curves, and decision curves in the internal and external validation cohorts, respectively. Both models demonstrated good discriminative ability between postoperative survival and recurrence risk, outperforming TNM staging in terms of predictive accuracy.

Study Timeline

• Study Start: 2022-12-10
• Primary Completion: 2023-08-20
• Status Verified: 2024-03
• Study Completion: 2024-03-20
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3820

Inclusion Criteria

1. gastroscopic histopathological diagnosis of gastric adenocarcinoma; 2) radical gastrectomy for GC; 3) preoperative examination of oxidative indicators including Fbg, CHOL, ALB, TBIL, DBIL, and CR within seven days before surgery; and 4) the tumor did not invade neighboring organs or had no distant metastasis.

Exclusion Criteria

1. gastroscopic histopathological diagnosis of non-adenocarcinoma, 2) gastric stump cancer, 3) neoadjuvant chemotherapy, 4) other malignant diseases besides GC, 5) incomplete medical records, and 6) patients with GC lost to follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5-year OS	5 years or 60 months	Overall survival, death, survival with tumor, deletion.
5-year DFS	5 years or 60 months	Disease-free survival, death,recurrence

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China