Multi-center and Multi-modal Deep Learning Study of Gastric Cancer

Sponsor
First Hospital of China Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05001321
Collaborator
The Second Hospital of Shandong University (Other), Chaoyang Central Hospital (Other), The General Hospital of Fushun Mining Bureau (Other), The fourth People's Hospital of Changzhou (Other), First Hospital of Jinzhou Medical University (Other)
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Study Details

Study Description

Brief Summary

To assist postoperative pathological diagnosis and classification of gastric cancer by machine learning; To improve the accuracy of pathological diagnosis of gastric cancer by machine learning; To predict the effectiveness of treatment for gastric cancer by deep learning; To construct a model to predict the survival of gastric cancer patients by multimodal deep learning.

Condition or Disease Intervention/Treatment Phase
  • Radiation: The whole abdomen contrast-enhanced CT scan
  • Other: H&E stained sections and slides

Study Design

Study Type:
Observational
Actual Enrollment :
3300 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Multi-center and Multi-modal Deep Learning Study of Diagnosis, Therapeutic Outcome and Prognosis of Gastric Cancer
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Training Group

Based on the inclusion criteria, 2000 gastric cancer patients will be recruited in the analysis. And a model will be constructed based on deep learning.

Radiation: The whole abdomen contrast-enhanced CT scan
All the participants were measured by the whole abdomen contrast-enhanced CT scan.

Other: H&E stained sections and slides
HE pathological examination was performed on all specimens of enrolled patients.

Internal Validation Group

Based on the inclusion criteria, 1000 gastric cancer patients will be recruited in this group to verify the sensitivity and specificity of the constructed model.

Radiation: The whole abdomen contrast-enhanced CT scan
All the participants were measured by the whole abdomen contrast-enhanced CT scan.

Other: H&E stained sections and slides
HE pathological examination was performed on all specimens of enrolled patients.

External Validation Group

Based on the inclusion criteria, 300 gastric cancer patients from 5 other medical centers will be recruited in this group to verify the sensitivity and specificity of the constructed model.

Radiation: The whole abdomen contrast-enhanced CT scan
All the participants were measured by the whole abdomen contrast-enhanced CT scan.

Other: H&E stained sections and slides
HE pathological examination was performed on all specimens of enrolled patients.

Outcome Measures

Primary Outcome Measures

  1. Maximum diameter of tumor [1 day]

    To measure the maximum diameter of tumor on preoperative enhanced abdominal CT of patients with gastric cancer.

  2. Growth pattern [1 day]

    To assess the growth pattern on preoperative enhanced abdominal CT of patients with gastric cancer, including endophytic, exophytic and mixed.

  3. Enhancement pattern [1 day]

    To assess the enhancement pattern on preoperative enhanced abdominal CT of patients with gastric cancer, including homogeneous and heterogeneous.

  4. Enhancement degree [1 day]

    To assess the enhancement degree on preoperative enhanced abdominal CT of patients with gastric cancer, including hypoenhancement, isoenhancement and hyperenhancement.

  5. Nucleus size [1 day]

    To obtain the nucleus size of postoperative H&E stained sections and slides of gastric cancer by deep learning.

  6. Nucleus shape [1 day]

    To obtain the nucleus shape of postoperative H&E stained sections and slides of gastric cancer by deep learning.

  7. Distribution of pixel intensity [1 day]

    To obtain the distribution of pixel intensity of postoperative H&E stained sections and slides of gastric cancer by deep learning.

  8. Texture of nuclei [1 day]

    To obtain the texture of nuclei of postoperative H&E stained sections and slides of gastric cancer by deep learning.

Secondary Outcome Measures

  1. Survival status [1 day]

    To analyze the survival status of patients with gastric cancer, involving dead and alive.

  2. Overall survival [1 day]

    To calculate the overall survival of patients with gastric cancer based on days to death and days to last follow-up.

  3. Recurrence/metastasis [1 day]

    To calculate the days to recurrence/metastasis of patients with gastric cancer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • The diagnosis of gastric cancer was confirmed by pathology;

  • Preoperative enhanced abdominal CT;

  • Available detailed clinical and pathological data;

  • Integrated follow-up data.

Exclusion Criteria:
  • The patients had severe underlying disease;

  • Overall survival was less than 3 months;

  • No detailed information could be collected.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The fourth People's Hospital of Changzhou Changzhou Jiangsu China 213001
2 Chaoyang Central Hospital Chaoyang Liaoning China 122099
3 The General Hospital of Fushun Mining Bureau Fushun Liaoning China 113012
4 First Hospital of Jinzhou Medical University Jinzhou Liaoning China 121012
5 The First Affiliated Hospital of China Medical University Shenyang Liaoning China 110000
6 The Second Hospital of Shandong University Ji'nan Shandong China 250033

Sponsors and Collaborators

  • First Hospital of China Medical University
  • The Second Hospital of Shandong University
  • Chaoyang Central Hospital
  • The General Hospital of Fushun Mining Bureau
  • The fourth People's Hospital of Changzhou
  • First Hospital of Jinzhou Medical University

Investigators

  • Principal Investigator: Kai Li, MD, First Hospital of China Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kai Li, Deputy Director of surgical Oncology, First Hospital of China Medical University
ClinicalTrials.gov Identifier:
NCT05001321
Other Study ID Numbers:
  • FirstHCMU_DL_oncology
First Posted:
Aug 11, 2021
Last Update Posted:
Aug 11, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kai Li, Deputy Director of surgical Oncology, First Hospital of China Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 11, 2021