An interventional study of HPV p16 and HPV testing - positive results in Oropharyngeal Carcinoma (OPC), sponsored by Masaryk Memorial Cancer Institute. Recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Masaryk Memorial Cancer Institute · Not applicable, Interventional, and Health services research
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).
369 studies on the registry are indexed under Oropharyngeal Neoplasms; 103 are open to participants now.
This study's planned enrollment of 35 is below the median of 52 across 265 interventional studies indexed under Oropharyngeal Neoplasms.
Browse Oropharyngeal Neoplasms studies →Masaryk Memorial Cancer Institute is the lead sponsor of 15 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
Diagnostic Test: HPV p16 · Diagnostic Test: HPV testing - positive results
The negative controls will be patients with OPC who are indicated for radiotherapy alone or concomitant chemoradiotherapy and who are p16-negative (approximately 10-15).
Diagnostic Test: HPV p16 · Diagnostic Test: HPV testing - negative results
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.
Also known as: oral swabs, oral cavity washings, peripheral blood samples
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.
Also known as: oral swabs, oral cavity washings, peripheral blood samples
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.
Also known as: oral swabs, oral cavity washings, peripheral blood samples
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
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.
Plan to share: Yes — IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.
Supporting information: Clinical study report
Time frame: after study completion
Access criteria: During the study, data will be managed in pseudonymized form in a protected database environment, available only for study team.After completion of the study, the data will be fully anonymized for publication purposes. All publication outputs of the study will be carried out by a team of researchers led by the principal investigator. The submission of each publication is subject to the approval of the principal investigator.The results of this study may be published or presented at scientific meetings after approval by the PI and always after anonymization of the subjects' personal data in accordance with Act No. 101/2000 Coll., on the protection of personal data.
Data sharing details ↗ · www.mou.cz
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Masaryk Memorial Cancer Institute