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NCT Number: NCT06035250

AI Prediction of Gastric Cancer Response to Neoadjuvant Chemotherapy

This study seeks to develop a deep-learning-based intelligent predictive model for the efficacy of neoadjuvant chemotherapy in gastric cancer patients. By utilizing the patients' CT imaging data, biopsy pathology images, and clinical information, the intelligent model will predict the post-neoadjuvant chemotherapy efficacy and prognosis, offering assistance in personalized treatment decisions for gastric cancer patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China

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About this study

This study seeks to develop a deep learning model to predict the outcomes of neoadjuvant chemotherapy in patients with gastric cancer. Leveraging participants' CT scans, biopsy pathology images, and clinical profiles, this model aims to forecast the effectiveness of post-neoadjuvant chemotherapy and the subsequent prognosis, thereby aiding in individualized treatment choices for these participants.

Data Collection: The investigators will gather data from 1,800 retrospective cases and 200 prospective cases from multiple hospitals. The retrospective data will be divided into training and testing sets to train and validate the model, respectively. The model's performance will subsequently be evaluated using the prospective dataset.

Clinical Information: This encompasses the participant's gender, age, tumor markers, staging, type, specific treatment plans, pre and post-treatment lab results, etc.

Imaging Data: CT imaging data taken within one month prior to the neoadjuvant chemotherapy, with at least the venous phase CT imaging included.

Pathology Data: Pathology images from a gastric tumor biopsy stained with Hematoxylin and Eosin (HE) taken within one month prior to treatment.

TRG Grading: Based on the pathology report of the surgical samples using the Ryan TRG grading system.

Prognostic Endpoints: The recorded endpoints are a 3-year progression-free survival (PFS) and a 5-year overall survival (OS). All deaths due to non-disease factors are excluded from the prognosis analysis.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18 years or older;
  • Pathologically diagnosed with advanced gastric cancer in accordance with the American AJCC's TNM staging standards;
  • Have not undergone any systematic anti-cancer treatments before neoadjuvant chemotherapy and have not had surgery for local progression or distant metastasis;
  • Received standard neoadjuvant chemotherapy as recommended by the clinical guidelines, and have documented treatment details;
  • CT imaging and biopsy pathology images strictly taken within one month prior to starting neoadjuvant treatment;
  • Patients possess comprehensive preoperative clinical information and post-operative TRG grading.

Exclusion criteria

  • Patients whose CT or pathology images are unclear, making lesion assessment infeasible;
  • Patients diagnosed with other concurrent tumors.

Treatment and study plan

Neoadjuvant chemotherapy

Drug

Participants in this group are diagnosed with gastric cancer and are scheduled to undergo neoadjuvant chemotherapy as a part of their treatment regimen. The specific chemotherapy drugs, dosages, and schedules will be determined according to established clinical guidelines and the participant's specific condition.

Primary outcomes

  1. Area under the receiver operating characteristic curve (AUC) for TRG prediction by the AI model

    Time frame: two months

    The AUC will be used to evaluate the performance of the AI model in predicting TRG grading of gastric cancer patients after neoadjuvant chemotherapy. An AUC of 1 indicates perfect prediction, while an AUC of 0.5 indicates prediction no better than chance.

  2. Accuracy of TRG prediction by the AI model

    Time frame: two months

    Accuracy measures the proportion of true positive and true negative predictions made by the AI model among all predictions. It indicates the capability of the model to correctly classify patients into their respective TRG gradings.

Secondary outcomes

  1. Progression-Free Survival (PFS) at 3 years

    Time frame: Three years

    The duration from the date of patient confirmation to the date of tumor progression or death of the patient, whichever occurs first.

  2. Overall Survival (OS) at 5 years

    Time frame: Five years

    The duration from the date of patient confirmation to the date of death of the patient.

Study contacts

Contact information is provided by the study sponsor or research team.

Di Dong, Ph.D.

CONTACT

[email protected]

+86 13811833760

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • Affiliated Cancer Hospital & Institute of Guangzhou Medical University
  • Cancer Hospital of Guangxi Medical University
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • First Affiliated Hospital, Sun Yat-Sen University
  • First Hospital of China Medical University
  • Fujian Cancer Hospital
  • Fujian Medical University Union Hospital
  • Henan Cancer Hospital
  • Nanfang Hospital, Southern Medical University
  • Peking Union Medical College Hospital
  • Peking University Cancer Hospital & Institute
  • Peking University People's Hospital
  • Ruijin Hospital
  • San Raffaele University Hospital, Italy
  • Sixth Affiliated Hospital, Sun Yat-sen University
  • The Affiliated Hospital of Qingdao University
  • The First Affiliated Hospital of Soochow University
  • The First Affiliated Hospital of Zhengzhou University
  • Tianjin Medical University Cancer Institute and Hospital
  • Xiangya Hospital of Central South University
  • Yunnan Cancer Hospital
  • Zhenjiang First People's Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2029
First posted
Sep 13, 2023
Registry last updated
Sep 28, 2023

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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