HPV-associated Oropharyngeal Carcinoma (HPV-OPC)

Condition(s) studied

Investigational drug(s) / intervention(s)

HPV p16: 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.

HPV testing - positive results: 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.

HPV testing - negative results: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR) — Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy
  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.

Trial sites (1)

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