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Completed

NCT Number: NCT07190040

Integrating Multi-Omics Data for Enhanced Prognosis Prediction in Gastric Cancer Post-Neoadjuvant Therapy

Study Protocol: Integrating Multi-Omics Data for Prognosis Prediction in Gastric Cancer Post-Neoadjuvant Therapy

Objective:

To develop and validate an integrative prognostic nomogram for patients with locally advanced gastric cancer (LAGC) undergoing neoadjuvant therapy, combining deep learning-derived radiomic features (DeepScore), transcriptome-based immune scores (ImmuneScore), and ypTNM staging.

Study Design:

A retrospective, single-center cohort study.

Participants:

A total of 179 LAGC patients who received neoadjuvant therapy followed by radical gastrectomy at Fujian Medical University Union Hospital between January 2019 and December 2022. Patients were divided into a training cohort (n = 125) and an independent validation cohort (n = 54).

Data Collection:

Baseline contrast-enhanced CT scans prior to neoadjuvant therapy were used for radiomic analysis. Postoperative tumor RNA sequencing data were used for immune profiling. Clinical and pathological data, including ypTNM stage, were collected from medical records.

Methods:

DeepScore: Extracted from CT images using a ResNet18-based deep learning model. Significant features were selected via univariate Cox and LASSO regression.

ImmuneScore: Calculated from RNA-seq data using the ESTIMATE algorithm to assess tumor immune infiltration.

Nomogram Construction: A multi-omics nomogram was developed using multivariate Cox regression incorporating DeepScore, ImmuneScore, and ypTNM stage.

Validation: Model performance was evaluated using time-dependent ROC analysis (AUC) and Kaplan-Meier survival analysis with log-rank tests in both cohorts.

Primary Outcomes:

Disease-free survival (DFS) and overall survival (OS).

Statistical Analysis:

Survival analyses were performed using Kaplan-Meier and Cox regression models. AUC values were computed for 1-, 2-, and 3-year DFS predictions. All analyses were conducted in R (v4.4.3).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fujian Medical University

Fuzhou, Fujian, 350001, China

Who can participate

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

Inclusion criteria

  • Gastric adenocarcinoma confirmed pathologically via gastroscopy;
  • Clinical staging of cT3/T4N0/+M0 with a history of receiving at least two cycles of neoadjuvant therapy
  • No prior history of other malignant tumors
  • Completion of radical gastrectomy

Exclusion criteria

  • Gastric cancer originating from the remnant stomach
  • Absence of baseline computed tomography (CT) data prior to treatment or suboptimal CT image quality that could compromise the accuracy of radiomic information extraction
  • Absence of postoperative transcriptome data

Treatment and study plan

Primary outcomes

  1. the Area Under the Curve

    Time frame: 2023.01.31-2025.05.31

    The model's predictive accuracy was evaluated by computing the Area Under the Curve for predicting 1-year, 2-year, and 3-year disease-free survival.

Secondary outcomes

  1. Disease-free survival

    Time frame: 2023.01.31-2025.05.31

    The log-rank test was utilized to compare disease-free survival and overall survival curves between these groups.

Other outcomes

  1. Overall survival

    Time frame: 2023.01.31-2025.05.31

    The log-rank test was utilized to compare disease-free survival and overall survival curves between these groups.

Sponsors and collaborators

Lead sponsor

Chang-Ming Huang, Prof.

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2025
First posted
Sep 24, 2025
Registry last updated
Sep 24, 2025

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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