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

Completed

• Conditions: Gastric Cancer (GC)

• Registration Number: NCT07190040
• Lead Sponsor: Chang-Ming Huang, Prof.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-12-31
• Status Verified: 2025-09
• Study Completion: 2025-09-01
• Study First Submitted: 2025-09-13
• Study First Submitted QC: 2025-09-22
• Last Update Submitted: 2025-09-22
• Study First Posted: 2025-09-24
• Last Update Posted: 2025-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Area Under the Curve	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 Outcome Measures

Name	Time	Method
Disease-free survival	2023.01.31-2025.05.31	The log-rank test was utilized to compare disease-free survival and overall survival curves between these groups.

Trial Locations

Locations (1)

Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China