Actively Recruiting

Age: 18Years +
All Genders
ID06035250

Deep Learning-Based Prediction of Gastric Cancer Response to Neoadjuvant Chemotherapy

Led by Chinese Academy of Sciences · Updated on 2023-09-28

200

Participants Needed

22

Research Sites

278 weeks

Total Duration

On this page

Sponsors

C

Chinese Academy of Sciences

Lead Sponsor

P

Peking University Cancer Hospital & Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are developing a deep learning model to predict how well patients with advanced gastric cancer will respond to neoadjuvant chemotherapy. This model uses data from patients' CT scans, biopsy pathology images, and clinical information to forecast the effectiveness of chemotherapy and the patient's prognosis. The study aims to assist personalized treatment decisions for gastric cancer patients by improving prediction accuracy. Participants diagnosed with advanced gastric cancer will undergo standard neoadjuvant chemotherapy according to clinical guidelines. Data collected include CT imaging taken within one month before treatment, pathology images from gastric tumor biopsies, and detailed clinical profiles such as tumor markers and staging. The study includes both retrospective data from 1,800 patients used for model training and validation, and prospective data from 200 patients for model performance evaluation. During the study, researchers will gather clinical, imaging, and pathology data to develop and test the AI model. The primary outcomes are the accuracy and area under the curve (AUC) for predicting tumor regression grade (TRG) within two months. Secondary outcomes include progression-free survival at three years and overall survival at five years. Participants' treatment details and prognosis will be closely monitored, with all study procedures designed to improve future personalized care for gastric cancer patients.

CONDITIONS

Brief Title

AI Prediction of Gastric Cancer Response to Neoadjuvant Chemotherapy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Pathologically diagnosed with advanced gastric cancer according to AJCC TNM staging
  • No prior systemic anti-cancer treatments before neoadjuvant chemotherapy
  • No surgery for local progression or distant metastasis before study
  • Receiving standard neoadjuvant chemotherapy as per clinical guidelines with documented treatment details
  • CT imaging and biopsy pathology images taken within one month before starting neoadjuvant treatment
  • Comprehensive preoperative clinical information and post-operative tumor regression grade (TRG) available
Not Eligible

You will not qualify if you...

  • Unclear CT or pathology images preventing lesion assessment
  • Diagnosis of any other concurrent tumors

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Varies according to specific chemotherapy regimen

Participants receive neoadjuvant chemotherapy according to established clinical guidelines to treat advanced gastric cancer.

Visits scheduled according to chemotherapy cycles as per clinical guidelines

Post-treatment Data Collection

Duration - Up to 2 months

Clinical, imaging, and pathology data are collected before and after neoadjuvant chemotherapy to develop and validate the AI prediction model.

1 visit for post-treatment assessment

Long-term Monitoring

Duration - Up to 5 years

Participants are monitored for progression-free survival and overall survival over several years to evaluate long-term outcomes.

Periodic follow-up visits over 3 to 5 years

Trial Site Locations

Total: 22 locations

1

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Not Yet Recruiting

2

Peking Union Medical College Hospital

Beijing, China

Not Yet Recruiting

3

Peking University Cancer Hospital & Institute

Beijing, China

Actively Recruiting

4

Peking University People's Hospital

Beijing, China

Not Yet Recruiting

5

Xiangya Hospital of Central South University

Changsha, China

Not Yet Recruiting

6

Fujian Cancer Hospital

Fuzhou, China

Not Yet Recruiting

7

Fujian Medical University Union Hospital

Fuzhou, China

Actively Recruiting

8

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Guangzhou, China

Not Yet Recruiting

9

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, China

Not Yet Recruiting

10

Nanfang Hospital of Southern Medical University

Guangzhou, China

Not Yet Recruiting

11

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, China

Actively Recruiting

12

Yunnan Cancer Hospital

Kunming, China

Actively Recruiting

13

Cancer Hospital of Guangxi Medical University

Nanning, China

Not Yet Recruiting

14

The Affiliated Hospital of Qingdao University

Qingdao, China

Not Yet Recruiting

15

Ruijin Hospital

Shanghai, China

Not Yet Recruiting

16

First Hospital of China Medical University

Shenyang, China

Not Yet Recruiting

17

The First Affiliated Hospital of Soochow University

Suzhou, China

Not Yet Recruiting

18

Tianjin Medical University Cancer Institute and Hospital

Tianjin, China

Not Yet Recruiting

19

Henan Cancer Hospital

Zhengzhou, China

Actively Recruiting

20

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Actively Recruiting

21

Zhenjiang First People's Hospital

Zhenjiang, China

Actively Recruiting

22

San Raffaele University Hospital, Italy

Milan, Italy

Actively Recruiting

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Research Team

D

Di Dong, Ph.D.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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