Malignant TumorNCT04793672
Establishment of Tongue Image Database and Machine Learning Model for Malignant Tumors Diagnosis
An observational study of Malignant Tumor, run by Zhejiang Cancer Hospital at 2 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.
- How many people
- 4,100 participants
- Where
- 2 sitesChina
- Study dates
- 1 May 2020to 30 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Histologically or cytologically confirmed malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital)
Hangzhou, Zhejiang, 310022
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
About this study
Official title: 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.
- Conditions
- Malignant Tumor
- Being tested
- Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.
- Keywords
- Malignant tumor, Tongue Image
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences of tongue images between patients with malignant tumors and healthy people.
Measured: 1 year
Overall Survival (OS)
Measured: 3 years
Secondary outcomes (1)
Disease free survival（DFS）
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 May 2020
- Primary completion31 Jan 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,100 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Zhejiang Hospital of TCM, Wenzhou Medical University, Fujian Cancer Hospital, RenJi Hospital, Zhejiang Provincial Tongde Hospital, Kecheng District People's Hospital, Yueyang Central Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, Harbin Cancer Hospital, Yuhang District People's Hospital, Hainan Cancer Hospital, Zigong Fourth People's Hospital, Henan University of Science and Technology, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Zhoushan Hospital, Zhejiang, Xianju People's Hospital, Fenghua District People's Hospital, Ningbo City, Shangyu People's Hospital of Shaoxing City
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
- Investigators
- Xiangdong Cheng, MD, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04793672
- Sponsor's protocol ID
- IRB-2019-56
- Status last verified
- Dec 2024
- First submitted
- 5 Mar 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Observational Clinical Study Observing the Differences of Tongue Images Between Patients With Malignant Tumors and Healthy People
- ClinicalTrials.gov ID
- NCT04793672
- Acronym / sponsor ID
- IRB-2019-56
- Conditions
- Malignant Tumor
- Keywords
- Malignant tumor, Tongue Image
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,100 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Sichuan Cancer Hospital and Research Institute, Zhejiang Hospital of TCM, Wenzhou Medical University, Fujian Cancer Hospital, RenJi Hospital, Zhejiang Provincial Tongde Hospital, Kecheng District People's Hospital, Yueyang Central Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Liaoning Cancer Hospital & Institute, Harbin Cancer Hospital, Yuhang District People's Hospital, Hainan Cancer Hospital, Zigong Fourth People's Hospital, Henan University of Science and Technology, The First People's Hospital of Changzhou, The First Affiliated Hospital of Soochow University, Zhoushan Hospital, Zhejiang, Xianju People's Hospital, Fenghua District People's Hospital, Ningbo City, Shangyu People's Hospital of Shaoxing City
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with malignant tumors and healthy people | – | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Histologically or cytologically confirmed malignant tumor，and no prior chemotherapy, radiotherapy, biotherapy, immunotherapy or other anti-tumor treatment for malignant tumor.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Patients with malignant tumors and healthy people |
Primary outcome
The differences of tongue images between patients with malignant tumors and healthy people.
Time frame: 1 year
Overall Survival (OS)
Time frame: 3 years
1 secondary outcome
Disease free survival（DFS）
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangdong Cheng, MD principal investigator
Zhejiang Cancer Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Tumor, run by Zhejiang Cancer Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences of tongue images between patients with malignant tumors and healthy people. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.