Predicting Gastric Cancer Response to Chemo With Multimodal AI Model

Gastric Cancer Clinical Trial

Official title:

A Radio-Pathomic Multimodal Machine Learning Model for Predicting Pathological Complete Response to Neoadjuvant Chemotherapy in Advanced Gastric Cancer: A Retrospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451393
• Other study ID #: E2021088
• Status: Recruiting
• Start date: February 1, 2013
• Est. completion date: December 30, 2026

Study information

• Verified date: June 2024
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Yonghe Chen, MD
• Phone: +86 135 6038 6150
• Email: chenyhe[@]mail2.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 30, 2026
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Neoadjuvant chemotherapy with radical tumor resection surgery
All patients were pathologically diagnosed as advanced gastric cancer, all receive neoadjuvant chemotherapy, after the completion of neoadjuvant chemotherapy, all patients receive radical tumor resection surgery (partial gastrectomy or total gastrectomy, as proper).

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological Complete Response	Pathological complete response (pCR) was defined as no viable cells remained in the primary tumor lesions and the dissected lymph nodes.	Assessed within 30 days after radical resection surgery.