Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics: a Multi-center Prospective Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Peritoneal Metastases
• Intervention / Treatment: Diagnostic test: Peritoneal metastasis status ascertainment

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.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Cancer Hospital & Institute
    • Contact: Lei Tang
  • Fuzhou, China
    • Recruiting
    • Fujian Medical University Union Hospital
    • Contact: Changming Huang, MD
  • Guangzhou, China
    • Recruiting
    • Nanfang Hospital of Southern Medical University
    • Contact: Guoxin Li
  • Guangzhou, China
    • Recruiting
    • Guangdong Provincial People's Hospital
    • Contact: Zaiyi Liu, MD
  • Guangzhou, China
    • Recruiting
    • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
    • Contact: Shuzhong Cui, MD
  • Guangzhou, China
    • Recruiting
    • Sun Yat-sen University Cancer Hospital
    • Contact: Linquan Tang, MD
  • Guiyang, China
    • Recruiting
    • Guizhou Provincial People's Hospital
    • Contact: Rongping Wang
  • Kunming, China
    • Recruiting
    • Yunnan Cancer Hospital
    • Contact: Zhenhui Li, MD
  • Taiyuan, China
    • Recruiting
    • Shanxi Province Cancer Hospital
    • Contact: Yanfen Cui, MD
  • Zhengzhou, China
    • Recruiting
    • Henan Cancer Hospital
    • Contact: Jing Li
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Jianbo Gao
  • Zhenjiang, China
    • Recruiting
    • Zhenjiang First People's Hospital
    • Contact: Xiuhong Shan
• Italy
  • Milan, Italy
    • Recruiting
    • Scientific Institute San Raffaele
    • Contact: Francesco De Cobelli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

13

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Peking University Cancer Hospital & Institute; Peking University Cancer Hospital & Institute collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Zhenjiang First People's Hospital; Zhenjiang First People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Nanfang Hospital of Southern Medical University; Nanfang Hospital of Southern Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Guizhou Provincial People's Hospital; Guizhou Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Henan Cancer Hospital; Henan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Yunnan Cancer Hospital; Yunnan Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Guangdong Provincial People's Hospital; Guangdong Provincial People's Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Guangzhou Medical University; Affiliated Cancer Hospital and Institute of Guangzhou Medical University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Fujian Medical University Union Hospital; Fujian Medical University Union Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Shanxi Province Cancer Hospital; Shanxi Province Cancer Hospital collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Sun Yat-sen University; Sun Yat-sen University collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.
Scientific Institute San Raffaele; Scientific Institute San Raffaele collects clinical information, preoperative CT images, and the golden standard for peritoneal metastasis status for each patient. Clinical information includes gender, age, gastric disease background, tumor markers, gastric cancer stage, gastric cancer type, treatment program, smoking history, alcohol history, etc. All patients undergo diagnostic laparoscopy. Any suspicious lesion discovered during laparoscopy is biopsied and pathologically examined to determine peritoneal metastasis status.	Diagnostic test: Peritoneal metastasis status ascertainment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Three years
Progression-free survival time	The progression-free survival time in patient subgroups stratified by the intelligent analysis system.	Three years
Overall survival	The overall survival time in patient subgroups stratified by the intelligent analysis system.	Three years

Collaborators and Investigators

• Sponsor: Chinese Academy of Sciences
• Collaborators: Shanxi Province Cancer Hospital; Sun Yat-sen University; Henan Cancer Hospital; Peking University Cancer Hospital & Institute; Nanfang Hospital of Southern Medical University; The First Affiliated Hospital of Zhengzhou University; Guangdong Provincial People's Hospital; Guizhou Provincial People's Hospital; Fujian Medical University Union Hospital; Zhenjiang First People's Hospital; Yunnan Cancer Hospital; Guangzhou Medical University; Beihang University; Scientific Institute San Raffaele

Publications and helpful links

General Publications

• Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available.
• Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008.
• Hur H, Lee HH, Jung H, Song KY, Jeon HM, Park CH. Predicting factors of unexpected peritoneal seeding in locally advanced gastric cancer: indications for staging laparoscopy. J Surg Oncol. 2010 Dec 1;102(7):753-7. doi: 10.1002/jso.21685.
• Burbidge S, Mahady K, Naik K. The role of CT and staging laparoscopy in the staging of gastric cancer. Clin Radiol. 2013 Mar;68(3):251-5. doi: 10.1016/j.crad.2012.07.015. Epub 2012 Sep 14.
• Dong D, Tang L, Li ZY, Fang MJ, Gao JB, Shan XH, Ying XJ, Sun YS, Fu J, Wang XX, Li LM, Li ZH, Zhang DF, Zhang Y, Li ZM, Shan F, Bu ZD, Tian J, Ji JF. Development and validation of an individualized nomogram to identify occult peritoneal metastasis in patients with advanced gastric cancer. Ann Oncol. 2019 Mar 1;30(3):431-438. doi: 10.1093/annonc/mdz001.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2028

Study Registration Dates

• First Submitted: December 30, 2022
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 10, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 12, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Gastric Cancer; Artificial Intelligence; Classification; Computed Tomography; Radiomics; Peritoneal Metastases
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Stomach Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: CASMI003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No