HPV-associated Oropharyngeal Carcinoma (HPV-OPC)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasaryk Memorial Cancer Institute

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HPV p16
  • HPV testing - positive results
  • HPV testing - negative results

Treatment groups

35 Participants
are divided into 2 treatment groups