Clinical trial · Interventional
HPV-associated Oropharyngeal Carcinoma (HPV-OPC)
Validation of a New Method for Monitoring HPV Infection in Patients With Head and Neck Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oropharyngeal Carcinoma (OPC) | Oropharyngeal Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV p16 | Diagnostic Test | — | UNRESOLVED |
| HPV testing - negative results | Diagnostic Test | — | UNRESOLVED |
| HPV testing - positive results | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- p16 positive OPC patients
- description
- 20 patients with OPC who were indicated for standard radiation therapy or concomitant chemoradiation therapy and who were p16-positive.
- interventionNames
- Diagnostic Test: HPV p16
- Diagnostic Test: HPV testing - positive results
- type
- ACTIVE_COMPARATOR
- label
- p16 negative OPC patients
- description
- 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).
- interventionNames
- Diagnostic Test: HPV p16
- Diagnostic Test: HPV testing - negative results
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (4)
- RESULTRettig 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. PMID 35262203
- RESULTDas 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. PMID 40925715
- RESULTIzadi 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. PMID 39420658
- RESULTIzadi 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. PMID 34753575