Nasopharyngeal Carcinoma (NPC)NCT07918755
Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
An observational study of Nasopharyngeal Carcinoma (NPC), run by Zhongshan People's Hospital, Guangdong, China at 2 sites in China.
Trial summary
An observational study combines retrospective and prospective cohorts to develop, validate, and compare models based on Epstein-Barr virus (EBV)-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination to support biopsy decisions for nasopharyngeal carcinoma (NPC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores
- How many people
- 1,500 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2026to 30 Jun 2028
- 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: The study population comprises individuals undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy for NPC risk assessment or suspected NPC at participating hospitals. The retrospective cohort will use existing clinical records, while the prospective cohort will enroll eligible individuals consecutively.
Who may be able to join
- Voluntarily agree to participate in the study and provide written informed consent;
- Be aged ≥18 years;
- Have available EBV-related serological test results or be able to provide blood samples for the relevant testing;
- Undergo nasopharyngeal endoscopy for nasopharyngeal carcinoma risk assessment or suspected nasopharyngeal carcinoma;
- Undergo nasopharyngeal biopsy as part of routine clinical care.
Who cannot join
- Previous confirmed diagnosis of nasopharyngeal carcinoma or prior treatment for nasopharyngeal carcinoma;
- Receipt of immunosuppressive therapy or other treatments that may affect serum antibody levels within the past 6 months;
- Severe organ dysfunction, including decompensated heart failure, respiratory failure, decompensated liver cirrhosis, or renal failure.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530022
Shenhong Qu, MD PhD, 86 15676172501, xhh2501@126.com
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403
Mingfang Ji, 86-0760-89880417, jmftbh@sina.com
About this study
An observational study combines retrospective and prospective cohorts to develop, validate, and compare models based on Epstein-Barr virus (EBV)-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination to support biopsy decisions for nasopharyngeal carcinoma (NPC). Existing clinical data will be analyzed retrospectively for model development and internal validation. Data from participants undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy at participating centers will be collected prospectively for external validation. The study will assess the models' diagnostic performance and potential value in identifying individuals who may benefit from biopsy and reducing unnecessary biopsies. Clinical decisions will follow routine practice.
Read the detailed description
The study includes a retrospective cohort for model development and internal validation and a prospective cohort for external validation at participating centers. Models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination will be developed, validated, and compared.
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores
- Keywords
- Nasopharyngeal Carcinoma (NPC), biomarkers, Endoscope, biopsy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scoresDiagnostic test
EBV-related blood biomarkers, including P85-Ab, EBNA1-IgA, and VCA-IgA, among others, will be evaluated together with nasopharyngeal endoscopic scores to support biopsy decisions for nasopharyngeal carcinoma. Biopsy and treatment decisions will follow routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Training Cohort | Participants selected from existing clinical records who underwent nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy for NPC risk assessment or suspected NPC. EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses will be analyzed for model development. Receives: Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores | |
| Internal Validation Cohort | Participants from the retrospective study population who are not included in the training cohort. Their EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses will be used for internal validation of the developed models. Receives: Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores | |
| External Validation Cohort | Participants undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy at participating centers will be enrolled prospectively. EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses from clinically indicated biopsies will be collected for external validation of the developed models. Clinical decisions will follow routine practice. Receives: Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of serological, endoscopic, and combined models at prespecified risk thresholds
Sensitivity and corresponding 95% confidence intervals will be assessed and compared across models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Specificity of serological, endoscopic, and combined models at prespecified risk thresholds
Specificity and corresponding 95% confidence intervals will be assessed and compared across models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Secondary outcomes (8)
Area under the receiver operating characteristic curve (AUC) of serological, endoscopic, and combined models
AUCs and corresponding 95% confidence intervals will be assessed and compared across models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Calibration intercept of serological, endoscopic, and combined models
The calibration intercept will be calculated for each model using predicted probabilities and histopathological diagnoses, separately in the internal validation cohort and the prospective external validation cohort. An intercept of 0 indicates ideal calibration in this respect.
Measured: Baseline
Calibration slope of serological, endoscopic, and combined models
The calibration slope will be calculated for each model using predicted probabilities and histopathological diagnoses, separately in the internal validation cohort and the prospective external validation cohort. A slope of 1 indicates ideal calibration in this respect.
Measured: Baseline
Brier score of serological, endoscopic, and combined models
The Brier score will be calculated for each model as the mean squared difference between predicted probabilities and histopathological outcomes, coded as 1 for nasopharyngeal carcinoma and 0 otherwise, separately in the internal validation cohort and the prospective external validation cohort. Scores range from 0 to 1, with lower scores indicating better overall predictive accuracy.
Measured: Baseline
Positive predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Positive predictive values and corresponding 95% confidence intervals will be calculated for each model at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Negative predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Negative predictive values and corresponding 95% confidence intervals will be calculated for each model at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Net benefit of model-based biopsy strategies
Decision curve analysis will be used to assess and compare the net benefit of biopsy strategies based on serological, endoscopic, and combined models with biopsy-all and biopsy-none strategies across risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Measured: Baseline
Potential percentage of biopsies avoided using model-based strategies at prespecified risk thresholds
For each serological, endoscopic, and combined model, the potential percentage of biopsies avoided will be calculated as the percentage of all evaluated participants undergoing biopsy whose predicted risk is below the prespecified threshold. This represents the potential reduction in biopsies relative to a biopsy-all strategy and will be assessed separately in the internal validation cohort and the prospective external validation cohort.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (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
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, China
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Principal investigator, Mingfang Ji, Zhongshan People's Hospital, Guangdong, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918755
- Sponsor's protocol ID
- NPC-2026-biopsymodel
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
- ClinicalTrials.gov ID
- NCT07918755
- Acronym / sponsor ID
- NPC-2026-biopsymodel
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- Nasopharyngeal Carcinoma (NPC), biomarkers, Endoscope, biopsy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Zhongshan People's Hospital, Guangdong, ChinaUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Nov 2026 (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.
An observational study combines retrospective and prospective cohorts to develop, validate, and compare models based on Epstein-Barr virus (EBV)-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination to support biopsy decisions for nasopharyngeal carcinoma (NPC). Existing clinical data will be analyzed retrospectively for model development and internal validation. Data from participants undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy at participating centers will be collected prospectively for external validation. The study will assess the models' diagnostic performance and potential value in identifying individuals who may benefit from biopsy and reducing unnecessary biopsies. Clinical decisions will follow routine practice.
Detailed description
The study includes a retrospective cohort for model development and internal validation and a prospective cohort for external validation at participating centers. Models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination will be developed, validated, and compared.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training Cohort | – | Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scoresParticipants selected from existing clinical records who underwent nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy for NPC risk assessment or suspected NPC. EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses will be analyzed for model development. |
| Internal Validation Cohort | – | Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scoresParticipants from the retrospective study population who are not included in the training cohort. Their EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses will be used for internal validation of the developed models. |
| External Validation Cohort | – | Diagnostic Test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scoresParticipants undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy at participating centers will be enrolled prospectively. EBV-related blood biomarker results, nasopharyngeal endoscopic scores, and pathological diagnoses from clinically indicated biopsies will be collected for external validation of the developed models. Clinical decisions will follow routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises individuals undergoing nasopharyngeal endoscopy and clinically indicated nasopharyngeal biopsy for NPC risk assessment or suspected NPC at participating hospitals. The retrospective cohort will use existing clinical records, while the prospective cohort will enroll eligible individuals consecutively.
Key inclusion criteria (5 listed)
- Voluntarily agree to participate in the study and provide written informed consent;
- Be aged ≥18 years;
- Have available EBV-related serological test results or be able to provide blood samples for the relevant testing;
- Undergo nasopharyngeal endoscopy for nasopharyngeal carcinoma risk assessment or suspected nasopharyngeal carcinoma;
- Undergo nasopharyngeal biopsy as part of routine clinical care.
Key exclusion criteria (3 listed)
- Previous confirmed diagnosis of nasopharyngeal carcinoma or prior treatment for nasopharyngeal carcinoma;
- Receipt of immunosuppressive therapy or other treatments that may affect serum antibody levels within the past 6 months;
- Severe organ dysfunction, including decompensated heart failure, respiratory failure, decompensated liver cirrhosis, or renal failure.
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 |
|---|---|---|
| Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scoresEBV-related blood biomarkers, including P85-Ab, EBNA1-IgA, and VCA-IgA, among others, will be evaluated together with nasopharyngeal endoscopic scores to support biopsy decisions for nasopharyngeal carcinoma. Biopsy and treatment decisions will follow routine clinical practice. | Diagnostic test | External Validation Cohort, Internal Validation Cohort, Training Cohort |
Primary outcome
Sensitivity of serological, endoscopic, and combined models at prespecified risk thresholds
Time frame: Baseline
Sensitivity and corresponding 95% confidence intervals will be assessed and compared across models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
Specificity of serological, endoscopic, and combined models at prespecified risk thresholds
Time frame: Baseline
Specificity and corresponding 95% confidence intervals will be assessed and compared across models based on EBV-related blood biomarkers alone, nasopharyngeal endoscopic scores alone, and their combination at prespecified risk thresholds, separately in the internal validation cohort and the prospective external validation cohort, using nasopharyngeal biopsy histopathology as the reference standard.
8 secondary outcomes
Area under the receiver operating characteristic curve (AUC) of serological, endoscopic, and combined models
Time frame: Baseline
Calibration intercept of serological, endoscopic, and combined models
Time frame: Baseline
Calibration slope of serological, endoscopic, and combined models
Time frame: Baseline
Brier score of serological, endoscopic, and combined models
Time frame: Baseline
Positive predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Time frame: Baseline
Negative predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Time frame: Baseline
Net benefit of model-based biopsy strategies
Time frame: Baseline
Potential percentage of biopsies avoided using model-based strategies at prespecified risk thresholds
Time frame: Baseline
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 5 Nov 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Nasopharyngeal Carcinoma (NPC)
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
Testing the Addition of BMS-986016 (Relatlimab) to the Usual Immunotherapy After Initial Treatment for Recurrent or Metastatic Nasopharyngeal Cancer
Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
Active, not recruitingPhase 2/3
Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers
Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Metastatic Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
Biomarkers in Patients With Respiratory Tract Dysplasia or Lung Cancer, Head and Neck Cancer, or Aerodigestive Tract Cancer and in Normal Volunteers
Esophageal Cancer, Head and Neck Cancer
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.
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 Nasopharyngeal Carcinoma (NPC), run by Zhongshan People's Hospital, Guangdong, China 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 5 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: opening soon, as of the sponsor's last update on 5 Nov 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?
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?
Contact Mingfang Ji (86-0760-89880417, jmftbh@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of serological, endoscopic, and combined models at prespecified risk thresholds (time frame: Baseline). 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 5 Nov 2026.