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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04793672
• Other study ID #: IRB-2019-56
• Status: Recruiting
• Start date: April 6, 2021
• Est. completion date: February 2, 2023

Study information

• Verified date: April 2021
• Source: Zhejiang Cancer Hospital
• Contact: Xiangdong Cheng, MD
• Phone: 0086-571-88128041
• Email: Chengxd516[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: February 2, 2023
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The differences of tongue images between patients with malignant tumors and healthy people.		1 year
Primary	Overall Survival (OS)		3 years
Secondary	Disease free survival(DFS)		1 year