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HPV-associated Oropharyngeal Carcinoma (HPV-OPC)

RecruitingNAAges 18 Years - anyAllMasaryk Memorial Cancer Institute
NCT07718620 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Masaryk Memorial Cancer Institute
Brno, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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