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

NCT04793672 | Completed

• 1 other identifier: IRB-2019-56
• Study Type: observational
• Target: 4,100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Malignant Tumor

Keywords

Malignant tumor; Tongue Image

Outcome Measures

Primary Outcomes (2)

• The differences of tongue images between patients with malignant tumors and healthy people.

  1 year

• Overall Survival (OS)

  3 years

Secondary Outcomes (1)

• Disease free survival（DFS）

  1 year

Study Arms (1)

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.

Interventions

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.

Patients with malignant tumors and healthy people

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead
• Sichuan Cancer Hospital and Research Institute: collaborator
• Zhejiang Hospital of TCM: collaborator
• Wenzhou Medical University: collaborator
• Fujian Cancer Hospital: collaborator
• RenJi Hospital: collaborator
• Tongde Hospital of Zhejiang: collaborator
• Kecheng District People's Hospital: collaborator
• Yueyang Central Hospital: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Harbin Cancer Hospital: collaborator
• Yuhang District People's Hospital: collaborator
• Hainan Cancer Hospital: collaborator
• Zigong Fourth People's Hospital: collaborator
• Henan University of Science and Technology: collaborator

Study Sites (2)

Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)

Hangzhou, Zhejiang, 310022, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Xiangdong Cheng, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Chief physician

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: March 11, 2021
• Study Start: May 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: December 1, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)