Clinical trial · Observational
Circulating Biomarkers in Oropharyngeal Cancers
The Use of Circulating Biomarkers in Oropharyngeal Cancer and Unknown Primary of Head and Neck - a Prospective Multicenter Study for Treatment Evaluation and Surveillance
- 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)
The goal of this observational longitudinal study is to learn about circulating tumor Human Papilloma Virus-DNA (ctHPV-DNA) as a biomarker for HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck. The main questions it aims to answer are: * Can ctHPV-DNA be used for treatment evaluation in HPV positive oropharyngeal cancer and cancer of unknown primary of the head and neck? * Can circulating HPV-DNA be used as a biomarker for recurrent disease during surveillance? Participants will be asked to leave plasma samples at diagnose, at the end of treatment and at every clinical follow-up. The patients are there own controls.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Base of the Tongue Carcinoma | Posterior Tongue Carcinoma | ALIAS | 0.90 |
| Oropharynx Cancer | Malignant Oropharyngeal Neoplasm | ALIAS | 0.90 |
| Oropharynx Squamous Cell Carcinoma | Oropharynx Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Tonsillar Cancer | Malignant Tonsillar Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The accuracy of ctHPV-DNA as a biomarker for recurrent disease, measured in PPV and NPV
- timeFrame
- 5 year follow-up
- description
- ctHPV-DNA will be evaluated by ddPCR. Two consecutive positive values will be defined as a molecular recurrance. The accuracy of the test will be presented with negative predictive value (NPV) and positive predictive value (PPV) at one, two (interim analysis) and at five year follow-up
Secondary outcomes (2)
- measure
- The correlation between molecular tumor burden (copies/mL) and radiological tumor burden (diameter and volume) using Kendall rank correlation coefficient.
- timeFrame
- 3 months follow-up
- description
- Correlation of ctHPV-DNA and radiologic tumor burden at diagnosis and post treatment. ctHPV-DNA will be evaluated by ddPCR (copies/mL) at diagnose and at the end of treatment. The levels of ctHPV-DNA will be used as a measure of molecular tumor burden. The molecular tumor burden will be compared with the radiologic tumor burden, measured in diameter and volume in the diagnostic and evaluation computed tomography. The correlation will be calculated using Kendall rank correlation coefficient
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Oropharyngeal cancer * Cancer of unknown primary in the head and neck Exclusion Criteria: * Previous treatment of cancer in the oropharynx. * Previous treatment of unknown primary tumor. * Remote metastases * Patients unwilling or unable to comply with the study protocol and follow-up schedule
References
Publications (2)
- DERIVEDAlmeren AO, Waenerlund M, Landstrom F, von Beckerath M, Qvick A, Carlsson J, Helenius G. Circulating Tumour DNA as a Complementary Tool for Treatment Evaluation in HPV-Associated Head and Neck Squamous Cell Carcinoma: An Observational Cohort Study. Clin Otolaryngol. 2025 Sep;50(5):831-839. doi: 10.1111/coa.14317. Epub 2025 Apr 22. PMID 40260766
- DERIVEDQvick A, Andersson E, Oldaeus Almeren A, Waenerlund M, Stenmark B, Karlsson C, Karlsson MG, Helenius G. Sensitive and Specific Droplet Digital PCR Assays for Circulating Tumor HPV DNA: Development, Validation, and Clinical Application in HPV-Associated Cancers. Mol Diagn Ther. 2024 Nov;28(6):835-845. doi: 10.1007/s40291-024-00743-9. Epub 2024 Sep 26. PMID 39325260