Nasopharyngeal Cancinoma (NPC)NCT07013461
International Collaborative Study on AJCC/UICC TNM-10 for Nasopharyngeal Cancer
An observational study of Nasopharyngeal Cancinoma (NPC), run by The University of Hong Kong-Shenzhen Hospital at 1 site in China.
Trial summary
The goal of this international, multicenter, prospective observational study is to improve prognostication and prediction of failure pattern for nasopharyngeal carcinoma (NPC), in order to provide more accurate guidance for personalized treatment decision. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2026to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled in participating centers
Who may be able to join
- All histologically confirmed nasopharyngeal carcinoma treated between 1 Oct 2025 and 30 Sep 2026
Who cannot join
- Non-epithelial tumors of nasopharynx (including lymphoma, sarcoma of soft tissue, bone/cartilagetumors. mucosal melanoma, salivary type tumors)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518009
Anne Lee, +86 755 8691 3333, awmlee@hku.hk
About this study
Official title: International Collaborative Study to Develop the AJCC/UICC TNM Version-Ten for Nasopharyngeal Cancer
The goal of this international, multicenter, prospective observational study is to improve prognostication and prediction of failure pattern for nasopharyngeal carcinoma (NPC), in order to provide more accurate guidance for personalized treatment decision. Firstly, we aim to improve the fundamental TNM staging system [The American Joint Committee on Cancer(AJCC)/Union for International Cancer Control(UICC) TNM Version-Nine] based on universally assessable anatomical parameters. Secondly, we aim to further refine prognostication for individual patients by integrating anatomical TNM parameters with non-anatomical factors and molecular biomarkers. In addition to the core group of participating centers from China (including Hong Kong) where NPC is most prevalent, the study will enrol patients from multiple countries/regions including those from non-endemic areas to provide global data. Patients treated with contemplary treatment methods during October 2025 to September 2026 will be recruited and they will be followed up for 5 years to generate detailed records for robust evaluation.
Key Questions:
Read more
- To achieve optimal improvement of anatomically based AJCC/UICC TNM Classification for global application
- To achieve precise prediction of failure pattern for individual patients by integration of TNM system and non-anatomical prognostic factors/molecular biomarkers Recruited patients with confirmed histological diagnosis of NPC will undergo standard clinical evaluations and receive treatment per institutional guidelines.
The anatomical extent of disease at presentation will be evaluated by experienced radiologists and oncologists. The patient will be followed up for 5 years and clinical outcome will be recorded for analyses on correlation with prognostic factors.
This study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries/regions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC/UICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.
Read the detailed description
Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus-associated malignancy with a striking geographical predominance, over 70% of global cases occur in East and Southeast Asia. The current AJCC/UICC TNM Version-Nine staging system, launched in January 2025, is a significant advancement in prognostic stratification. The recommendations are based by high quality retrospective data from Mainland China and Hong Kong and consensus building among international multidisciplinary experts, taking into consideration both the statistical evidence of benefit and clinical applicability.
Recent years have witnessed transformative changes in NPC treatment paradigms, including advancements in radiotherapy techniques, the integration of immune checkpoint inhibitors, and intensified treatment for metastatic disease. In addition, studies have demonstrated the independent prognostic value of non-anatomical factors such as circulating Epstein-Barr virus (EBV) DNA levels, and various hematologic biomarkers. These developments necessitate continual improvement of the TNM staging system to align with contemporary management with diagnostic and therapeutic advancements.
This international, multicenter, prospective observational study is designed to address these critical requirements to generate high-quality evidence for developing the next generation TNM staging system (AJCC/UICC Version-Ten). The study will enroll all consecutive histopathological confirmed NPC patients treated during October 2025 and September 2026 from leading cancer centers worldwide. Detailed data on clinicopathological characteristics, imaging findings, molecular markers (including EBV-DNA), treatment and outcome will be collected and analyzed.
The primary endpoint of the study is overall survival (OS), while secondary endpoints focus on the pattern of failure at different sites: local failure-free survival (L-FFS), regional nodal failure-free survival (N-FFS), and distant failure-free survival (D-FFS). Correlation of these outcomes to anatomical and non-anatomical factors will be analyzed.
This study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries/regions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC/UICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with histologically confirmed NPC | All enrolled patients will receive diagnosis and treatment according to the standard clinical practice of each participating center. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
The time to death for any cause
Measured: 5 years
Secondary outcomes (3)
Local Failure Free Survival (LFFS)
The time to local tumor persistence/recurrence.
Measured: 5 years
Regional Nodal Failure Free Survival (N-FFS)
The time to regional nodal persistence/recurrence
Measured: 5 years
Distant Failure-Free Survival (D-FFS)
The time to the first occurrence of distant metastases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start9 Jan 2026
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong-Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Chinese Academy of Medical Sciences, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sichuan Cancer Hospital and Research Institute, First Affiliated Hospital of Fujian Medical University, Queen Mary Hospital, Hong Kong, The Queen Elizabeth Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, United Christian Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Fudan University, Hunan Cancer Hospital, National Cancer Centre, Singapore, Sun Yat-Sen University Cancer Center, Tuen Mun Hospital
- Responsible party
- Principal investigator, Anne Wing-mui Lee, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07013461
- Sponsor's protocol ID
- hkuszh2025075
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Collaborative Study to Develop the AJCC/UICC TNM Version-Ten for Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT07013461
- Acronym / sponsor ID
- hkuszh2025075
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- The University of Hong Kong-Shenzhen HospitalUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Chinese Academy of Medical Sciences, Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Sichuan Cancer Hospital and Research Institute, First Affiliated Hospital of Fujian Medical University, Queen Mary Hospital, Hong Kong, The Queen Elizabeth Hospital, Pamela Youde Nethersole Eastern Hospital, Princess Margaret Hospital, Hong Kong, United Christian Hospital, Prince of Wales Hospital, Shatin, Hong Kong, Fudan University, Hunan Cancer Hospital, National Cancer Centre, Singapore, Sun Yat-Sen University Cancer Center, Tuen Mun Hospital
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 10 Jun 2025 (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 goal of this international, multicenter, prospective observational study is to improve prognostication and prediction of failure pattern for nasopharyngeal carcinoma (NPC), in order to provide more accurate guidance for personalized treatment decision. Firstly, we aim to improve the fundamental TNM staging system [The American Joint Committee on Cancer(AJCC)/Union for International Cancer Control(UICC) TNM Version-Nine] based on universally assessable anatomical parameters. Secondly, we aim to further refine prognostication for individual patients by integrating anatomical TNM parameters with non-anatomical factors and molecular biomarkers. In addition to the core group of participating centers from China (including Hong Kong) where NPC is most prevalent, the study will enrol patients from multiple countries/regions including those from non-endemic areas to provide global data. Patients treated with contemplary treatment methods during October 2025 to September 2026 will be recruited and they will be followed up for 5 years to generate detailed records for robust evaluation.
Key Questions:
- To achieve optimal improvement of anatomically based AJCC/UICC TNM Classification for global application
- To achieve precise prediction of failure pattern for individual patients by integration of TNM system and non-anatomical prognostic factors/molecular biomarkers Recruited patients with confirmed histological diagnosis of NPC will undergo standard clinical evaluations and receive treatment per institutional guidelines.
The anatomical extent of disease at presentation will be evaluated by experienced radiologists and oncologists. The patient will be followed up for 5 years and clinical outcome will be recorded for analyses on correlation with prognostic factors.
This study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries/regions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC/UICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.
Detailed description
Nasopharyngeal carcinoma (NPC) is an Epstein-Barr virus-associated malignancy with a striking geographical predominance, over 70% of global cases occur in East and Southeast Asia. The current AJCC/UICC TNM Version-Nine staging system, launched in January 2025, is a significant advancement in prognostic stratification. The recommendations are based by high quality retrospective data from Mainland China and Hong Kong and consensus building among international multidisciplinary experts, taking into consideration both the statistical evidence of benefit and clinical applicability.
Recent years have witnessed transformative changes in NPC treatment paradigms, including advancements in radiotherapy techniques, the integration of immune checkpoint inhibitors, and intensified treatment for metastatic disease. In addition, studies have demonstrated the independent prognostic value of non-anatomical factors such as circulating Epstein-Barr virus (EBV) DNA levels, and various hematologic biomarkers. These developments necessitate continual improvement of the TNM staging system to align with contemporary management with diagnostic and therapeutic advancements.
This international, multicenter, prospective observational study is designed to address these critical requirements to generate high-quality evidence for developing the next generation TNM staging system (AJCC/UICC Version-Ten). The study will enroll all consecutive histopathological confirmed NPC patients treated during October 2025 and September 2026 from leading cancer centers worldwide. Detailed data on clinicopathological characteristics, imaging findings, molecular markers (including EBV-DNA), treatment and outcome will be collected and analyzed.
The primary endpoint of the study is overall survival (OS), while secondary endpoints focus on the pattern of failure at different sites: local failure-free survival (L-FFS), regional nodal failure-free survival (N-FFS), and distant failure-free survival (D-FFS). Correlation of these outcomes to anatomical and non-anatomical factors will be analyzed.
This study will be another important milestone for NPC staging because firstly, this is the first time that the data are based on prospective data to ensure comprehensive coverage of all essential evidence; and secondly, this is the first time that centers from non-endemic countries/regions will also participate to ensure that the final recommendations are globally applicable. The findings will provide valuable evidence for the development of the AJCC/UICC TNM Version-Ten staging system and prognostic system to improve risk stratification for designing personalized treatment strategy, ultimately leading to improvement of patient outcome and patient selection for future research worldwide.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with histologically confirmed NPC | – | –All enrolled patients will receive diagnosis and treatment according to the standard clinical practice of each participating center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in participating centers
Key inclusion criteria (1 listed)
- All histologically confirmed nasopharyngeal carcinoma treated between 1 Oct 2025 and 30 Sep 2026
Key exclusion criteria (1 listed)
- Non-epithelial tumors of nasopharynx (including lymphoma, sarcoma of soft tissue, bone/cartilagetumors. mucosal melanoma, salivary type tumors)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 5 years
The time to death for any cause
3 secondary outcomes
Local Failure Free Survival (LFFS)
Time frame: 5 years
Regional Nodal Failure Free Survival (N-FFS)
Time frame: 5 years
Distant Failure-Free Survival (D-FFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Cancinoma (NPC), run by The University of Hong Kong-Shenzhen Hospital at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 5 years). 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 4 May 2026.