NCT07718620|RecruitingDMC
HPV-associated Oropharyngeal Carcinoma (HPV-OPC)
HPV-OPC
Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers
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HPV-OPC
Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers
Sponsor study identifier
interventional
35
1 country
1
Study Start
May 25, 2026
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 25, 2026
Actual (reported)July 7, 2026
Actual (reported)July 22, 2026
Actual (reported)March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
Baseline (pre-treatment), Week 4 of radiotherapy, end of radiotherapy (approx. Week 7), and 3 months post-radiotherapy.
20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
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).
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.
Masaryk Memorial Cancer Institute
Brno, Czech Republic, 65653, Czechia
Rettig EM, Faden DL, Sandhu S, Wong K, Faquin WC, Warinner C, Stephens P, Kumar S, Kuperwasser C, Richmon JD, Uppaluri R, Varvares M, Sethi R, Hanna GJ, Sroussi H. Detection of circulating tumor human papillomavirus DNA before diagnosis of HPV-positive head and neck cancer. Int J Cancer. 2022 Oct 1;151(7):1081-1085. doi: 10.1002/ijc.33996. Epub 2022 Mar 16.
Das D, Hirayama S, Aye L, Bryan ME, Naegele S, Zhao B, Efthymiou V, Mendel J, Fisch AS, Guan Z, Kroller L, Michels BE, Waterboer T, Richmon JD, Adalsteinsson V, Lawrence MS, Crowson MG, Iafrate AJ, Faden DL. Circulating tumor human papillomavirus DNA whole genome sequencing enables human papillomavirus-associated oropharynx cancer early detection. J Natl Cancer Inst. 2026 Jan 1;118(1):58-67. doi: 10.1093/jnci/djaf249.
Tomáš Novotný, MUDr.
Masaryk Memorial Cancer Institute
First Submitted
July 7, 2026
First Posted
July 22, 2026
Study Start
May 25, 2026
Actual (reported)Primary Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Izadi N, Strmiskova J, Anton M, Hausnerova J, Bartosik M. LAMP-based electrochemical platform for monitoring HPV genome integration at the mRNA level associated with higher risk of cervical cancer progression. J Med Virol. 2024 Oct;96(10):e70008. doi: 10.1002/jmv.70008.
Izadi N, Sebuyoya R, Moranova L, Hrstka R, Anton M, Bartosik M. Electrochemical bioassay coupled to LAMP reaction for determination of high-risk HPV infection in crude lysates. Anal Chim Acta. 2021 Dec 1;1187:339145. doi: 10.1016/j.aca.2021.339145. Epub 2021 Oct 5.
Study Completion
March 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 22, 2026
Record last verified: 2026-07
IPD to be shared in pseudonymized form during the study.IPD to be published in anonymized form.
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Source: ClinicalTrials.gov.
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