Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese Academy of Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
(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.
Trial population
All included patients are initially diagnosed as peritoneal metastasis-negative by CT, but later confirmed with the actual peritoneal metastasis status in laparoscopic exploration.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Peritoneal metastasis status ascertainment
Diagnostic testEach 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.
Treatment groups
400 Participants
are divided into 13 treatment groups13
Treatment groupsSee each treatment group below.
Group A: Peking University Cancer Hospital & Institute1 intervention
Group B: Zhenjiang First People's Hospital1 intervention
Group C: The First Affiliated Hospital of Zhengzhou University1 intervention
Group D: Nanfang Hospital of Southern Medical University1 intervention
Group E: Guizhou Provincial People's Hospital1 intervention
Group F: Henan Cancer Hospital1 intervention
Group G: Yunnan Cancer Hospital1 intervention
Group H: Guangdong Provincial People's Hospital1 intervention
Group I: Guangzhou Medical University1 intervention
Group J: Fujian Medical University Union Hospital1 intervention
Group K: Shanxi Province Cancer Hospital1 intervention
Group L: Sun Yat-sen University1 intervention
Group M: Scientific Institute San Raffaele1 intervention
Trial outcomes
Primary outcomes
1
The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system
AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.
Time frame
three monthsSecondary outcomes
1
The accuray of intelligent analysis system in predicting peritoneal metastasis
The agreement between the prediction outcome of intelligent analysis system and the golden standard of peritoneal metastasis.
Time frame
three monthsOther outcomes
1
The statistical significance of intelligent analysis system in risk stratification
Statistical significance (P value) of progression-free survival (PFS) in gastric cancer patients between high-risk and low-risk group identified by the intelligent analysis system.
Time frame
Three years2
Progression-free survival time
The progression-free survival time in patient subgroups stratified by the intelligent analysis system.
Time frame
Three years3
Overall survival
The overall survival time in patient subgroups stratified by the intelligent analysis system.
Time frame
Three yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Chinese Academy of Sciences
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
Zhenjiang First People's Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Guizhou Provincial People's Hospital
Collaborator
Henan Cancer Hospital
Collaborator
Yunnan Cancer Hospital
Collaborator
Guangdong Provincial People's Hospital
Collaborator
Guangzhou Medical University
Collaborator
Fujian Medical University Union Hospital
Collaborator
Shanxi Province Cancer Hospital
Collaborator
Sun Yat-sen University
Collaborator
Beihang University
Collaborator
Scientific Institute San Raffaele
Collaborator
Source ClinicalTrials.gov