Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05722275

Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital & Institute, Beijing, China

Loading trial locations.

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peritoneal metastasis status ascertainment

Diagnostic Test

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.

Primary outcomes

  1. The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system

    Time frame: three months

    AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.

Secondary outcomes

  1. The accuray of intelligent analysis system in predicting peritoneal metastasis

    Time frame: three months

    The agreement between the prediction outcome of intelligent analysis system and the golden standard of peritoneal metastasis.

Other outcomes

  1. The statistical significance of intelligent analysis system in risk stratification

    Time frame: Three years

    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.

  2. Progression-free survival time

    Time frame: Three years

    The progression-free survival time in patient subgroups stratified by the intelligent analysis system.

  3. Overall survival

    Time frame: Three years

    The overall survival time in patient subgroups stratified by the intelligent analysis system.

Study contacts

Contact information is provided by the study sponsor or research team.

Di Dong, Ph.D

CONTACT

[email protected]

+86 010-82618465

Yali Zang, Ph.D

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2028
First posted
Feb 10, 2023
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.