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Trial Title: Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

NCT ID: NCT05722275

Condition: Gastric Cancer
Peritoneal Metastases

Conditions: Official terms:
Neoplasm Metastasis
Stomach Neoplasms

Conditions: Keywords:
Artificial Intelligence
Classification
Gastric Cancer
Peritoneal Metastases
Computed Tomography
Radiomics

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Peritoneal metastasis status ascertainment
Description: Each participant with gastric cancer will undergo enhanced CT examination for detection of peritoneal metastasis. Within two weeks of CT examination, the participant will undergo diagnostic laparoscopy to confirm the status of peritoneal metastasis.
Arm group label: Fujian Medical University Union Hospital
Arm group label: Guangdong Provincial People's Hospital
Arm group label: Guangzhou Medical University
Arm group label: Guizhou Provincial People's Hospital
Arm group label: Henan Cancer Hospital
Arm group label: Nanfang Hospital of Southern Medical University
Arm group label: Peking University Cancer Hospital & Institute
Arm group label: Scientific Institute San Raffaele
Arm group label: Shanxi Province Cancer Hospital
Arm group label: Sun Yat-sen University
Arm group label: The First Affiliated Hospital of Zhengzhou University
Arm group label: Yunnan Cancer Hospital
Arm group label: Zhenjiang First People's Hospital

Summary: Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Detailed description: Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Criteria for eligibility:

Study pop:
All included patients are initially diagnosed as peritoneal metastasis-negative by CT, but later confirmed with the actual peritoneal metastasis status in laparoscopic exploration.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - (1) diagnosed advanced gastric cancer (≥cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound; - (2) with both enhanced CT and laparoscopy; - (3) without typical peritoneal metastasis indications in CT (diffuse omental nodules or omental cake, large amount of ascites, obvious irregular thickening with high peritoneal enhancement); - (4) without other evidence of distant metastasis, and no stage IV features on CT. Exclusion Criteria: - (1) previous abdominal surgery; - (2) previous abdominal malignancies or inflammatory diseases; - (3) time intervals between CT and laparoscopy longer than 2 weeks; - (4) CT image artifacts that undermine peritoneal lesion assessment.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking University Cancer Hospital & Institute

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Lei Tang

Facility:
Name: Fujian Medical University Union Hospital

Address:
City: Fuzhou
Country: China

Status: Recruiting

Contact:
Last name: Changming Huang, MD

Facility:
Name: Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Shuzhong Cui, MD

Facility:
Name: Guangdong Provincial People's Hospital

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Zaiyi Liu, MD

Facility:
Name: Nanfang Hospital of Southern Medical University

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Guoxin Li

Facility:
Name: Sun Yat-Sen University Cancer Hospital

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Linquan Tang, MD

Facility:
Name: Guizhou Provincial People's Hospital

Address:
City: Guiyang
Country: China

Status: Recruiting

Contact:
Last name: Rongping Wang

Facility:
Name: Yunnan Cancer Hospital

Address:
City: Kunming
Country: China

Status: Recruiting

Contact:
Last name: Zhenhui Li, MD

Facility:
Name: Shanxi Province Cancer Hospital

Address:
City: Taiyuan
Country: China

Status: Recruiting

Contact:
Last name: Yanfen Cui, MD

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Country: China

Status: Recruiting

Contact:
Last name: Jing Li

Facility:
Name: The First Affiliated Hospital of Zhengzhou University

Address:
City: Zhengzhou
Country: China

Status: Recruiting

Contact:
Last name: Jianbo Gao

Facility:
Name: Zhenjiang First People's Hospital

Address:
City: Zhenjiang
Country: China

Status: Recruiting

Contact:
Last name: Xiuhong Shan

Facility:
Name: Scientific Institute San Raffaele

Address:
City: Milan
Country: Italy

Status: Recruiting

Contact:
Last name: Francesco De Cobelli

Start date: January 1, 2023

Completion date: December 31, 2028

Lead sponsor:
Agency: Chinese Academy of Sciences
Agency class: Other

Collaborator:
Agency: Peking University Cancer Hospital & Institute
Agency class: Other

Collaborator:
Agency: Zhenjiang First People's Hospital
Agency class: Other

Collaborator:
Agency: The First Affiliated Hospital of Zhengzhou University
Agency class: Other

Collaborator:
Agency: Nanfang Hospital, Southern Medical University
Agency class: Other

Collaborator:
Agency: Guizhou Provincial People's Hospital
Agency class: Other

Collaborator:
Agency: Henan Cancer Hospital
Agency class: Other

Collaborator:
Agency: Yunnan Cancer Hospital
Agency class: Other

Collaborator:
Agency: Guangdong Provincial People's Hospital
Agency class: Other

Collaborator:
Agency: Guangzhou Medical University
Agency class: Other

Collaborator:
Agency: Fujian Medical University Union Hospital
Agency class: Other

Collaborator:
Agency: Shanxi Province Cancer Hospital
Agency class: Other

Collaborator:
Agency: Sun Yat-sen University
Agency class: Other

Collaborator:
Agency: Beihang University
Agency class: Other

Collaborator:
Agency: Scientific Institute San Raffaele
Agency class: Other

Source: Chinese Academy of Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05722275

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