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Completed

NCT Number: NCT06337279

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

  • 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.

Treatment and study plan

Primary outcomes

  1. 5-year OS

    Time frame: 5 years or 60 months

    Overall survival, death, survival with tumor, deletion.

  2. 5-year DFS

    Time frame: 5 years or 60 months

    Disease-free survival, death,recurrence

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Collaborators

  • Fujian Medical University Union Hospital

Registry information

Official study title

The Clinical Value of Systemic Oxidative Stress Score in Predicting Long-term Survival and Recurrence Risk in Gastric Cancer: A Multicenter Real-world Cohort Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 29, 2024
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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