Establishment of Tongue Image Database and Machine Learning Model for Malignant Tumors Diagnosis

A Multi-center Observational Clinical Study Observing the Differences of Tongue Images Between Patients With Malignant Tumors and Healthy People

The tongue images of malignant tumors and corresponding healthy people will be collected to establish the tongue image database. Deep learning will be carried out by computer and artificial intelligence to construct the early screening, diagnosis, prognosis and prognosis model of various malignant tumors based on tongue image for the diagnosis and treatment of malignant tumors.

Study Overview

• Status: Completed
• Conditions: Malignant Tumor
• Intervention / Treatment: Other: Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.

• Study Type: Observational
• Enrollment (Actual): 4100

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310022
      • Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Histologically or cytologically confirmed malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.

Description

Inclusion Criteria:

• 18≤age≤80
• Histologically or cytologically confirmed malignant tumor
• No prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor
• Subject volunteers to join the study, Signs informed consent, has good compliance and can cooperate with follow-up

Exclusion Criteria:

• Two or more kinds of malignant tumors at the same time
• Malignant tumor that has been treated by chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor therapy
• Subjects who had other factors that might force them to terminate the research ahead of time, such as the development of other severe disease (including mental disease) that required combined treatment, seriously abnormal laboratory examination value, and family or social factors that might affect the subject safety or experimental data collection, as judged by the researchers

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with malignant tumors and healthy people; Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.	Other: Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.; Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	3 years
The differences of tongue images between patients with malignant tumors and healthy people.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Disease free survival（DFS）	1 year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Collaborators: Wenzhou Medical University; Shanxi Province Cancer Hospital; Fujian Cancer Hospital; RenJi Hospital; Shandong Cancer Hospital and Institute; Liaoning Tumor Hospital & Institute; Sichuan Cancer Hospital and Research Institute; Yueyang Central Hospital; Hainan Cancer Hospital; Henan University of Science and Technology; Tongde Hospital of Zhejiang; Kecheng District People's Hospital; Harbin Cancer Hospital; Yuhang District People's Hospital; Zigong Fourth People's Hospital; Zhejiang Hospital of TCM
• Investigators: Principal Investigator: Xiangdong Cheng, MD, Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Malignant tumor; Tongue Image
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRB-2019-56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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