HPV-positive Oropharyngeal Carcinoma: tracking HPV in saliva, washings and blood during radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study follows adults with HPV-positive head and neck cancer, mainly oropharyngeal carcinoma, who are planned for curative radiotherapy or concurrent chemoradiation. Researchers will collect oral swabs, oral cavity washings, and plasma at baseline and during treatment to measure HPV DNA with a new electrochemical assay, comparing results to standard qPCR. The goal is to understand how HPV viral load changes over time and whether monitoring can support treatment de-escalation in selected patients. A small control group of p16-negative OPC patients will be included for comparison. The study is conducted at Masaryk Memorial Cancer Institute in Brno, Czech Republic, with an estimated enrollment of about 20 HPV-positive and 10–15 p16-negative patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Masaryk Memorial Cancer Institute
  Brno, Czech Republic, Czechia Recruiting

Study contacts

• Principal investigator: Tomáš Novotný, MUDr. — Masaryk Memorial Cancer Institute
• Study coordinator: Martina Lojová, PhD
• Email: martina.lojova@mou.cz
• Phone: +420543136232

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant chemoimmunotherapy with PD-1 blockade to reduce surgery for advanced head and neck cancer

  This approach will try a short course of chemotherapy plus the PD-1 drug toripalimab before standard treatment for people with advanced head and neck cancers to shrink tumors and allow less extensive surgery or radiation.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07209189

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.