Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

Recruiting

• Conditions: Chemotherapy Effect; Gastric Cancer
• Interventions: Drug: Neoadjuvant chemotherapy with radical tumor resection surgery

• Registration Number: NCT06451393
• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Brief Summary

This study aims to develop a multimodal model combining radiomic and pathomic features to predict pathological complete response (pCR) in advanced gastric cancer patients undergoing neoadjuvant chemotherapy (NAC). The researchers intended to collected pre-intervention CT images and pathological slides from patients, extract radiomic and pathomic features, and build a prediction model using machine learning algorithms. The model will be validated using a separate cohort of patients. This research intend to build a radiomic-pathomic model that can outperform models based on either radiomic or pathomic features alone, aiming to improve the prediction of pCR in gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-01
• Primary Completion: 2022-09-30
• Status Verified: 2024-06
• Study First Submitted: 2024-06-04
• Study First Submitted QC: 2024-06-08
• Last Update Submitted: 2024-06-08
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-11
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients with histologically confirmed adenocarcinoma of the stomach or esophagogastric junction who received NAC and radical gastrectomy;
• patients who underwent abdominal multidetector computed tomography (CT) inspection, gastroscope, and tumor tissue biopsy before any intervention started;
• Lesions that are assessable according to The Response Evaluation Criteria in Solid Tumors Version 1.1

Exclusion Criteria

• Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection;
• patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling;
• patients with insufficient data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neoadjuvant chemotherapy with radical tumor resection surgery	Neoadjuvant chemotherapy with radical tumor resection surgery	(i) Patients with indistinguishable tumor lesions on the CT images due to insufficient filling of the stomach during the CT inspection; (ii) patients without indistinguishable tumor cell on the pathological slides due to inadequate sampling; (iii) patients with insufficient data.

Primary Outcome Measures

Name	Time	Method
Pathological Complete Response	Assessed within 30 days after radical resection surgery.	Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.

Trial Locations

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China