Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features

November 1, 2026 updated by: Mingfang Ji, Zhongshan People's Hospital, Guangdong, China

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Zhongshan, Guangdong, China, 528403
        • Zhongshan City People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530022
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  1. Voluntarily agree to participate in the study and provide written informed consent;
  2. Be aged ≥18 years;
  3. Have available EBV-related serological test results or be able to provide blood samples for the relevant testing;
  4. Undergo nasopharyngeal endoscopy for nasopharyngeal carcinoma risk assessment or suspected nasopharyngeal carcinoma;
  5. Undergo nasopharyngeal biopsy as part of routine clinical care.

Exclusion Criteria:

  1. Previous confirmed diagnosis of nasopharyngeal carcinoma or prior treatment for nasopharyngeal carcinoma;
  2. Receipt of immunosuppressive therapy or other treatments that may affect serum antibody levels within the past 6 months;
  3. Severe organ dysfunction, including decompensated heart failure, respiratory failure, decompensated liver cirrhosis, or renal failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: OTHER

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores

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.
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.
Diagnostic test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores

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.
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.
Diagnostic test: Assessment of EBV-related blood biomarkers and nasopharyngeal endoscopic scores

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic curve (AUC) of serological, endoscopic, and combined models
Time Frame: Baseline

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.
Baseline
Calibration intercept of serological, endoscopic, and combined models
Time Frame: Baseline

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.
Baseline
Calibration slope of serological, endoscopic, and combined models
Time Frame: Baseline

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.
Baseline
Brier score of serological, endoscopic, and combined models
Time Frame: Baseline

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.
Baseline
Positive predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Time Frame: Baseline

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.
Baseline
Negative predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Time Frame: Baseline

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.
Baseline
Net benefit of model-based biopsy strategies
Time Frame: Baseline

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.
Baseline
Potential percentage of biopsies avoided using model-based strategies at prespecified risk thresholds
Time Frame: Baseline

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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhongshan People's Hospital, Guangdong, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
People's Hospital of Guangxi Zhuang Autonomous Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPC-2026-biopsymodel

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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