Development and Validation of a Biopsy Decision Model for Nasopharyngeal Carcinoma Based on Serological Markers and Endoscopic Features
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Mingfang Ji
- Numéro de téléphone: 86-0760-89880417
- E-mail: jmftbh@sina.com
Lieux d'étude
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Guangdong
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Zhongshan, Guangdong, Chine, 528403
- Zhongshan City People's Hospital
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Contact:
- Mingfang Ji
- Numéro de téléphone: 86-0760-89880417
- E-mail: jmftbh@sina.com
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Guangxi
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Nanning, Guangxi, Chine, 530022
- People's Hospital of Guangxi Zhuang Autonomous Region
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Contact:
- Shenhong Qu, MD PhD
- Numéro de téléphone: 86 15676172501
- E-mail: xhh2501@126.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: OTHER
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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. |
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. |
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. |
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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Sensitivity of serological, endoscopic, and combined models at prespecified risk thresholds
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUC) of serological, endoscopic, and combined models
Délai: 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
Délai: 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
|
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Calibration slope of serological, endoscopic, and combined models
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies stomatognathiques
- Tumeurs par site
- Tumeurs
- Tumeurs par type histologique
- Tumeurs de la tête et du cou
- Tumeurs, glandulaires et épithéliales
- Carcinome
- Maladies oto-rhino-laryngologiques
- Tumeurs pharyngées
- Tumeurs oto-rhino-laryngologiques
- Maladies nasopharyngées
- Maladies pharyngées
- Tumeurs du nasopharynx
- Carcinome du nasopharynx
Autres numéros d'identification d'étude
- NPC-2026-biopsymodel
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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