HPV-associated Oropharyngeal Carcinoma (HPV-OPC)

Masaryk Memorial Cancer Institute35 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Oropharyngeal Carcinoma (OPC)

Interventions

HPV p16DIAGNOSTIC_TEST

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 resultsDIAGNOSTIC_TEST

HPV testing - negative resultsDIAGNOSTIC_TEST

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)

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.

Time frame: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy

Secondary Outcomes

Change From Baseline in HPV16 Viral Load in Plasma, Oral Swabs, and Oral Rinses

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.

Time frame: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.