NCT07013461

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
69mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Dec 2031

First Submitted

Initial submission to the registry

June 1, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

January 9, 2026

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

6 years

First QC Date

June 1, 2025

Last Update Submit

April 28, 2026

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The time to death for any cause

    5 years

Secondary Outcomes (3)

  • Local Failure Free Survival (LFFS)

    5 years

  • Regional Nodal Failure Free Survival (N-FFS)

    5 years

  • Distant Failure-Free Survival (D-FFS)

    5 years

Study Arms (1)

Patients with histologically confirmed NPC

All enrolled patients will receive diagnosis and treatment according to the standard clinical practice of each participating center.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled in participating centers

You may qualify if:

  • All histologically confirmed nasopharyngeal carcinoma treated between 1 Oct 2025 and 30 Sep 2026

You may not qualify if:

  • Non-epithelial tumors of nasopharynx (including lymphoma, sarcoma of soft tissue, bone/cartilagetumors. mucosal melanoma, salivary type tumors)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518009, China

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, Clinical Cancer Center

Study Record Dates

First Submitted

June 1, 2025

First Posted

June 10, 2025

Study Start

January 9, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

CN(1)