Testing a computer based virtual patient tool to help doctors find a rare head and neck cancer earlier
| ISRCTN | ISRCTN42747002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42747002 |
| Sponsor | Jinan University |
| Funder | National Key Research and Development Program of China |
- Submission date
- 13/04/2026
- Registration date
- 15/04/2026
- Last edited
- 14/04/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Nasopharyngeal carcinoma is a rare type of cancer that starts in the nasopharynx, which is the upper part of the throat behind the nose. It is more common in some parts of southern China than in Europe. Early stages often cause few or no clear symptoms, which means the cancer is sometimes found late. This study aims to find out whether a new computer based tool, called a digital twin system, can improve existing screening tests so that this cancer can be found earlier and more accurately. The digital twin uses health data to create a virtual model of a person to help estimate their risk of disease.
Who can participate?
Adults aged 30 years to 69 years who live in Zhongshan City in Guangdong Province, China may be able to take part. Participants must already be involved in the local screening programme for nasopharyngeal carcinoma and must not have had this cancer before. People with serious ongoing illnesses or conditions that affect their immune system cannot take part.
What does the study involve?
Participants will take part in routine blood tests that are already used in screening programmes. These tests look for antibodies linked to Epstein-Barr virus, which is known to increase the risk of nasopharyngeal carcinoma. Information such as age, sex, and family history of this cancer will also be collected. For some participants, this information will then be analysed using the digital twin system to estimate cancer risk. Depending on the risk level, some people may be asked to attend follow-up tests such as a throat examination. No experimental treatments are given.
What are the possible benefits and risks of participating?
Participants may benefit from having their risk of cancer assessed more accurately, which could help find the disease earlier if it is present. Early detection usually gives a better chance of successful treatment. There are no extra medical risks beyond standard screening tests, as the study does not add new procedures or treatments. Blood tests and examinations are part of routine care.
Where is the study run from?
The study is run from The First Affiliated Hospital of Jinan University and the Cancer Research Institute of Zhongshan City People’s Hospital, both based in China.
When is the study starting and how long is it expected to run for?
The study is planned to start in April 2026. It is expected to run until December 2028.
Who is funding the study?
The study is funded by the National Key Research and Development Program of China.
Who is the main contact?
Professor Shuixing Zhang, shui7515@126.com
Contact information
Principal investigator, Public, Scientific
Department of Radiology, The First Affiliated Hospital of Jinan University
Guangzhou
510620
China
 ORCID ID |
0000-0001-7377-382X |
|---|---|
| Phone | +86 13544597585 |
| shui7515@126.com |
Study information
| Primary study design | Observational |
|---|---|
| Observational study design | Cohort study |
| Scientific title | Diagnostic efficacy of a digital twin system for early screening of nasopharyngeal carcinoma |
| Study objectives | To prospectively validate the performance of the Digital Twin System combined with traditional Epstein-Barr virus (EBV) serological screening in improving the positive predictive value for nasopharyngeal carcinoma (NPC) screening in the high-incidence area of Zhongshan, Guangdong. |
| Ethics approval(s) |
Approved 01/04/2026, Medical Ethics Committee of Jinan University (Jinan University, Guangzhou, 510620, China; +86 020-85220250; oykyc@jnu.edu.can), ref: JNUECKY-20260325-007 |
| Health condition(s) or problem(s) studied | Nasopharyngeal carcinoma screening |
| Intervention | Study design: Prospective cohort study. Study population: Local residents aged 30–69 years in Zhongshan, Guangdong, who participated in NPC screening from January 1 to December 31, 2026; inclusion requires no history of NPC and signed informed consent. process: Collect serological and epidemiological data (gender, age, family history) of medium- and high-risk populations; Further stratify risk via the HD model to determine follow-up measures (nasopharyngoscopy or serological follow-up). Outcome analysis: Calculate core diagnostic indicators; compare efficacy with serological screening alone; conduct cost-effectiveness analysis (cost-effectiveness ratio [CER], incremental cost-effectiveness ratio [ICER]). |
| Intervention type | Not Specified |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 01/12/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 30 Years |
| Upper age limit | 69 Years |
| Sex | All |
| Target sample size at registration | 10000 |
| Key inclusion criteria | 1. Registered population aged 30–69 years in the screening area (Zhongshan City) 2. No previous history of nasopharyngeal carcinoma 3. Participants who agreed to sign the informed consent form |
| Key exclusion criteria | 1. Patients with severe cardiac, cerebral, hepatic, pulmonary or renal diseases 2. Patients with severe immune system diseases 3. Patients currently receiving glucocorticoid or immunosuppressive therapy 4. Individuals with poor mental status and impaired consciousness |
| Date of first enrolment | 15/04/2026 |
| Date of final enrolment | 01/12/2028 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
14/04/2026: Trial's existence confirmed by Medical Ethics Committee of Jinan University.
