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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation of HPV DNA Levels Measured by a New Electrochemical Method Versus Standard Quantitative Polymerase Chain Reaction (qPCR)
Timeframe: Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy