Clinical trial NCT05722275: Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics
Official title: Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics: a Multi-center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Peritoneal Metastases
Keywords: Artificial Intelligence
Classification
Gastric Cancer
Peritoneal Metastases
Computed Tomography
Radiomics
Lead sponsor: Chinese Academy of Sciences
Sponsor class: OTHER_GOV
Collaborators: name: Peking University Cancer Hospital & Institute
name: Zhenjiang First People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Nanfang Hospital, Southern Medical University
name: Guizhou Provincial People's Hospital
name: Henan Cancer Hospital
name: Yunnan Cancer Hospital
name: Guangdong Provincial People's Hospital
name: Guangzhou Medical University
name: Fujian Medical University Union Hospital
name: Shanxi Province Cancer Hospital
name: Sun Yat-sen University
name: Beihang University
name: Scientific Institute San Raffaele
First posted: 2023-02-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system
timeFrame: three months
Secondary outcomes:
measure: The accuray of intelligent analysis system in predicting peritoneal metastasis
timeFrame: three months
Other outcomes:
measure: The statistical significance of intelligent analysis system in risk stratification
timeFrame: Three years
measure: Progression-free survival time
timeFrame: Three years
measure: Overall survival
timeFrame: Three years
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital & Institute
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Affiliated Cancer Hospital and Institute of Guangzhou Medical University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Hospital
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
city: Kunming
country: China
facility: Yunnan Cancer Hospital
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
city: Zhenjiang
country: China
facility: Zhenjiang First People's Hospital
city: Milan
country: Italy
facility: Scientific Institute San Raffaele
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.