HPV-associated Oropharyngeal Carcinoma (HPV-OPC) (HPV-OPC)
17 de julio de 2026 actualizado por: Masaryk Memorial Cancer Institute
Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers
This study focuses on the longitudinal monitoring of HPV infection in patients with head and neck cancers, particularly oropharyngeal carcinoma (OPC), using a new electrochemical detection method.
This method has already been successfully developed and validated for cervical cancer.
The aim of the project is to monitor the dynamics of HPV viral load before the start of treatment and during conservative radiation therapy or concurrent chemoradiation therapy.
HPV will be analyzed from oral swabs, oral cavity washings, and plasma as part of a small prospective study.
The results of the new method will be correlated with standard techniques, particularly qPCR.
Longitudinal monitoring may contribute to the individualization and potential de-escalation of treatment in selected patients.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Patients with HPV-positive head and neck tumors, primarily OPC, who are indicated for conservative radiation therapy or concurrent chemoradiation therapy will be enrolled in the study.
At defined time points (before the start of treatment and during treatment), oral swabs, oral cavity washings, and peripheral blood samples will be collected, from which plasma will be isolated for analysis of viral ctDNA.
We estimate approximately 20 patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-positive.
Negative controls will be patients with OPC indicated for radiotherapy alone or concurrent chemoradiotherapy who are p16-negative (approximately 10-15).
Tipo de estudio
Intervencionista
Inscripción (Estimado)
35
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Martina Lojová, PhD
- Número de teléfono: +420543136232
- Correo electrónico: martina.lojova@mou.cz
Copia de seguridad de contactos de estudio
- Nombre: Martin Bartošík, PhD
- Número de teléfono: +420543133306
- Correo electrónico: martin.bartosik@mou.cz
Ubicaciones de estudio
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Czech Republic
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Brno, Czech Republic, Chequia, 65653
- Reclutamiento
- Masaryk Memorial Cancer Institute
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Contacto:
- Martina Lojová, PhD
- Número de teléfono: +420543136232
- Correo electrónico: martina.lojova@mou.cz
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Contacto:
- Martin Martošík, PhD
- Número de teléfono: +420543133306
- Correo electrónico: martin.bartosik@mou.cz
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Investigador principal:
- Tomáš Novotný, MUDr.
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- a patient with an oropharyngeal tumor indicated for curative radiation therapy or chemoradiotherapy
- if radiation therapy or chemoradiotherapy was preceded by surgery, the patient may be enrolled if the lesion persists on imaging studies
- the lesion must be a histologically confirmed squamous cell carcinoma with known p16 status
- age ≥ 18 years
- the subject must be willing and able to provide written informed consent for specimen collection
- ability to communicate effectively with the investigator in the local language, and ability to understand and comply with the study requirements
Exclusion Criteria:
- previous induction chemotherapy
- unknown p16 status, incomplete or inadequate histology-e.g., adenocarcinoma, melanoma, lymphoma,
- previous radiation therapy to the oropharynx
- palliative patients indicated for accelerated radiation therapy with a treatment duration of < 5.5 weeks
- age < 18 years
- pregnant or breastfeeding women
- patients in the terminal stage of life
- severe alcohol and/or drug abuse during treatment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: p16 positive OPC patients
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
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Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients.
We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity.
By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Otros nombres:
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients.
We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity.
By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Otros nombres:
|
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Comparador activo: p16 negative OPC patients
The negative controls will be patients with OPC who are indicated for radiotherapy alone or concomitant chemoradiotherapy and who are p16-negative (approximately 10-15).
|
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients.
We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity.
By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Otros nombres:
Monitoring changes in HPV DNA levels during therapy can predict the clinical response to treatment and, in the future, may allow for the safe de-escalation of the intensity of radiation therapy or chemoradiation in selected patients.
We will also determine the appropriate method for collecting DNA samples so that, in the future, sampling can be as minimally invasive as possible while maintaining the necessary sensitivity and specificity.
By comparing the dynamics of local mucosal samples with those of blood samples, we can observe how these dynamics differ in the event of a local or systemic relapse.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
Periodo de tiempo: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
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Assessment of the diagnostic agreement between a novel electrochemical biosensor and the standard qPCR method for detecting HPV infection in patients with HPV-positive oropharyngeal cancer (OPC).
Data will be reported as the correlation coefficient and sensitivity/specificity of the electrochemical method relative to the gold standard.
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Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses
Periodo de tiempo: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
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Quantification of HPV16 DNA concentration (measured in copies/mL) across three distinct matrices: (a) circulating DNA extracted from plasma, (b) oral swabs, and (c) oral rinses.
Measurements will be performed using both standard quantitative PCR (qPCR) and the new electrochemical biosensor to track viral clearance dynamics during and after treatment.
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Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Tomáš Novotný, MUDr., Masaryk Memorial Cancer Institute
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Rettig EM, Faden DL, Sandhu S, Wong K, Faquin WC, Warinner C, Stephens P, Kumar S, Kuperwasser C, Richmon JD, Uppaluri R, Varvares M, Sethi R, Hanna GJ, Sroussi H. Detection of circulating tumor human papillomavirus DNA before diagnosis of HPV-positive head and neck cancer. Int J Cancer. 2022 Oct 1;151(7):1081-1085. doi: 10.1002/ijc.33996. Epub 2022 Mar 16.
- Das D, Hirayama S, Aye L, Bryan ME, Naegele S, Zhao B, Efthymiou V, Mendel J, Fisch AS, Guan Z, Kroller L, Michels BE, Waterboer T, Richmon JD, Adalsteinsson V, Lawrence MS, Crowson MG, Iafrate AJ, Faden DL. Circulating tumor human papillomavirus DNA whole genome sequencing enables human papillomavirus-associated oropharynx cancer early detection. J Natl Cancer Inst. 2026 Jan 1;118(1):58-67. doi: 10.1093/jnci/djaf249.
- Izadi N, Strmiskova J, Anton M, Hausnerova J, Bartosik M. LAMP-based electrochemical platform for monitoring HPV genome integration at the mRNA level associated with higher risk of cervical cancer progression. J Med Virol. 2024 Oct;96(10):e70008. doi: 10.1002/jmv.70008.
- Izadi N, Sebuyoya R, Moranova L, Hrstka R, Anton M, Bartosik M. Electrochemical bioassay coupled to LAMP reaction for determination of high-risk HPV infection in crude lysates. Anal Chim Acta. 2021 Dec 1;1187:339145. doi: 10.1016/j.aca.2021.339145. Epub 2021 Oct 5.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
25 de mayo de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de marzo de 2027
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
22 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A6/26
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.
Marco de tiempo para compartir IPD
after study completion
Criterios de acceso compartido de IPD
During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.After completion of the study, the data will be fully anonymized for publication purposes.
All publication outputs of the study will be carried out by a team of researchers led by the principal investigator.
The submission of each publication is subject to the approval of the principal investigator.The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.
Tipo de información de apoyo para compartir IPD
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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