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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Mingfang Ji
- Número de telefone: 86-0760-89880417
- E-mail: jmftbh@sina.com
Locais de estudo
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Guangdong
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Zhongshan, Guangdong, China, 528403
- Zhongshan City People's Hospital
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Contato:
- Mingfang Ji
- Número de telefone: 86-0760-89880417
- E-mail: jmftbh@sina.com
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Guangxi
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Nanning, Guangxi, China, 530022
- People's Hospital of Guangxi Zhuang Autonomous Region
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Contato:
- Shenhong Qu, MD PhD
- Número de telefone: 86 15676172501
- E-mail: xhh2501@126.com
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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.
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: OTHER
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Sensitivity of serological, endoscopic, and combined models at prespecified risk thresholds
Prazo: 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
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Specificity of serological, endoscopic, and combined models at prespecified risk thresholds
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area under the receiver operating characteristic curve (AUC) of serological, endoscopic, and combined models
Prazo: 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
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Calibration intercept of serological, endoscopic, and combined models
Prazo: Baseline
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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
Prazo: 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
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Brier score of serological, endoscopic, and combined models
Prazo: 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
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Positive predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Prazo: 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
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Negative predictive value of serological, endoscopic, and combined models at prespecified risk thresholds
Prazo: 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
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Net benefit of model-based biopsy strategies
Prazo: 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
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Potential percentage of biopsies avoided using model-based strategies at prespecified risk thresholds
Prazo: Baseline
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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
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças estomatognáticas
- Neoplasias por local
- Neoplasias
- Neoplasias por Tipo Histológico
- Neoplasias de Cabeça e Pescoço
- Neoplasias Glandulares e Epiteliais
- Carcinoma
- Doenças Otorrinolaringológicas
- Neoplasias faríngeas
- Neoplasias Otorrinolaringológicas
- Doenças Nasofaríngeas
- Doenças Faríngeas
- Neoplasias Nasofaríngeas
- Carcinoma nasofaringeal
Outros números de identificação do estudo
- NPC-2026-biopsymodel
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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