Clinical trial NCT04793672: Establishment of Tongue Image Database and Machine Learning Model for Malignant Tumors Diagnosis
Official title: A Multi-center Observational Clinical Study Observing the Differences of Tongue Images Between Patients With Malignant Tumors and Healthy People
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Malignant Tumor
Keywords: Malignant tumor
Tongue Image
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan Cancer Hospital and Research Institute
name: Zhejiang Hospital of TCM
name: Wenzhou Medical University
name: Fujian Cancer Hospital
name: RenJi Hospital
name: Tongde Hospital of Zhejiang
name: Kecheng District People's Hospital
name: Yueyang Central Hospital
name: Shandong Cancer Hospital and Institute
name: Shanxi Province Cancer Hospital
name: Liaoning Cancer Hospital & Institute
name: Harbin Cancer Hospital
name: Yuhang District People's Hospital
name: Hainan Cancer Hospital
name: Zigong Fourth People's Hospital
name: Henan University of Science and Technology
First posted: 2021-03-11
Enrollment: 4100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The differences of tongue images between patients with malignant tumors and healthy people.
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: 3 years
Secondary outcomes:
measure: Disease free survival（DFS）
timeFrame: 1 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiangdong Cheng, MD
role: PRINCIPAL_INVESTIGATOR
References: