Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
| Yunnan Cancer Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gastric Cancer Patients Undergoing Neoadjuvant Chemotherapy | This group comprises participants diagnosed with advanced gastric cancer. The participants will be treated with standard neoadjuvant chemotherapy regimens recommended by clinical guidelines. Treatment details, including the generic name of the drugs, dosage form, dosage, frequency, and duration, will be recorded according to the specific regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the receiver operating characteristic curve (AUC) for TRG prediction by the AI model | 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. | two months |
| Accuracy of TRG prediction by the AI model | 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. | two months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) at 3 years | The duration from the date of patient confirmation to the date of tumor progression or death of the patient, whichever occurs first. | Three years |
| Overall Survival (OS) at 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
The study population comprises gastric cancer patients from various hospitals. Participants are individuals diagnosed with advanced gastric cancer and are currently undergoing neoadjuvant chemotherapy treatments. Selection is based on criteria such as age, specific diagnosis, past treatment history, and the clarity of their medical images and pathology images.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Di Dong, Ph.D. | Contact | +86 13811833760 | di.dong@ia.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yali Zang, Ph.D. | Institute of Automation, Chinese Academy of Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting | Beijing | China |
Individual participant data (IPD) may be made available to other researchers upon request. Interested researchers should present a reasonable research proposal and a data usage application. All participating units of this study will review and assess the proposal and application to determine whether to share the data.
Data will become available 1 year after study completion and will remain available for a period of 5 years.
Interested researchers should submit a detailed research proposal and a data usage application for review. All participating units of this study will assess the application to determine eligibility for data access.
Not provided
| Henan Cancer Hospital |
| OTHER_GOV |
| Zhenjiang First People's Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
| Cancer Hospital of Guangxi Medical University | OTHER |
| Peking University People's Hospital | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| The Affiliated Hospital of Qingdao University | OTHER |
| Ruijin Hospital | OTHER |
| Sixth Affiliated Hospital, Sun Yat-sen University | OTHER |
| Peking Union Medical College Hospital | OTHER |
| Xiangya Hospital of Central South University | OTHER |
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| Fujian Cancer Hospital | OTHER_GOV |
| San Raffaele University Hospital, Italy | OTHER |
Not provided
Not provided
Not provided
The biospecimens consist of gastric tumor biopsy samples, collected from each patient prior to the initiation of neoadjuvant chemotherapy. These specimens undergo HE (Hematoxylin and Eosin) staining for pathology imaging.
|
The duration from the date of patient confirmation to the date of death of the patient.
| Five years |
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | China |
|
| Peking University Cancer Hospital & Institute | Recruiting | Beijing | China |
|
| Peking University People's Hospital | Not yet recruiting | Beijing | China |
|
| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | China |
|
| Fujian Cancer Hospital | Not yet recruiting | Fuzhou | China |
|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | China |
|
| Affiliated Cancer Hospital & Institute of Guangzhou Medical University | Not yet recruiting | Guangzhou | China |
|
| First Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Guangzhou | China |
|
| Nanfang Hospital of Southern Medical University | Not yet recruiting | Guangzhou | China |
|
| Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | Guangzhou | China |
|
| Yunnan Cancer Hospital | Recruiting | Kunming | China |
|
| Cancer Hospital of Guangxi Medical University | Not yet recruiting | Nanning | China |
|
| The Affiliated Hospital of Qingdao University | Not yet recruiting | Qingdao | China |
|
| Ruijin Hospital | Not yet recruiting | Shanghai | China |
|
| First Hospital of China Medical University | Not yet recruiting | Shenyang | China |
|
| The First Affiliated Hospital of Soochow University | Not yet recruiting | Suzhou | China |
|
| Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | Tianjin | China |
|
| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
|
| Zhenjiang First People's Hospital | Recruiting | Zhenjiang | China |
|
| San Raffaele University Hospital, Italy | Recruiting | Milan | Italy |
|
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
Not provided
Not provided