Tumor Mutational Burden, Liquid Biopsy, Angiogenic Factors and DCE-MRI Perfusion in HPV-Negative Oropharyngeal Cancer

NCT07407205 — Not applicable, Active not recruiting, 30 participants, Institute of Oncology Ljubljana

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Tumor Mutational Burden, Liquid Biopsy, Angiogenic Factors and Magnetic Resonance Perfusion in Predicting Response to Chemoradiotherapy in HPV-Negative Oropharyngeal Squamous Cell Carcinoma and Disease Course After Treatment

Registry	NCT07407205
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	30 (Estimated)
Sponsor	Institute of Oncology Ljubljana (Other)
Conditions	Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal HPV Squamous Cell Carcinoma
Interventions	Concurrent Chemoradiotherapy, Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI) (Procedure, diagnostic test)
Dates	start 2019-06-10, primary completion 2025-12-31, completion 2026-12-31 (estimated), first posted 2026-02-12, last updated 2026-02-17
Locations	1 site in Slovenia

-Summary

This prospective interventional study evaluates the predictive value of tumor mutational burden, liquid biopsy biomarkers (including circulating tumor DNA), angiogenic factors, and dynamic contrast-enhanced magnetic resonance (MR) perfusion imaging in patients with HPV-negative oropharyngeal squamous cell carcinoma treated with concurrent chemoradiotherapy. The aim is to improve prediction of treatment response and disease course after treatment, support decision-making regarding optimal therapy, and potentially reduce the number of imaging examinations required during follow-up.

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+Detailed description

Patients with HPV-negative oropharyngeal squamous cell carcinoma treated with standard concurrent chemoradiotherapy are prospectively included in this study. The study investigates tumor mutational burden and specific somatic mutations in tumor tissue, as well as circulating tumor DNA (ctDNA) and other molecular biomarkers obtained through liquid biopsy. In addition, angiogenic factors in plasma and microRNA in extracellular vesicles are analyzed and compared with quantitative parameters obtained from dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) perfusion.

The main objective is to gain additional insight into tumor biology during and after chemoradiotherapy and to identify prognostic and predictive biomarkers associated with treatment response and disease progression. The study also aims to assess whether biomarker-based monitoring may reduce the need for repeated imaging examinations while maintaining accurate evaluation of treatment response and follow-up.

+Arms and interventions

Arm	Type	Interventions	Description
Concurrent Chemoradiotherapy	Experimental	Procedure: Concurrent Chemoradiotherapy; Diagnostic Test: Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)	Patients with HPV-negative oropharyngeal squamous cell carcinoma treated with standard concurrent chemoradiotherapy. Participants undergo additional diagnostic procedures including blood sampling for liquid biopsy biomarkers and dynamic contrast-enhanced MRI perfusion imaging for evaluation of predictive and prognostic markers.

Concurrent Chemoradiotherapy (Procedure): Standard-of-care concurrent chemoradiotherapy administered for HPV-negative oropharyngeal squamous cell carcinoma according to institutional treatment protocols.
Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI) (Diagnostic test): Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) perfusion performed before and/or during treatment to obtain quantitative perfusion parameters and evaluate their predictive value for treatment response.

+Outcome measures

Primary outcomes

Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy [Up to 6 months after completion of concurrent chemoradiotherapy]
Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy [Up to 6 months after completion of concurrent chemoradiotherapy]: Association of tumor mutational burden, somatic mutations (tumor tissue and/or ctDNA), liquid biopsy biomarkers (ctDNA, angiogenic factors, microRNA in extracellular vesicles), and dynamic contrast-enhanced MRI (DCE-MRI) perfusion parameters with treatment response after concurrent chemoradiotherapy in HPV-negative oropharyngeal squamous cell carcinoma.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥ 18 years
* Histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma
* Planned treatment with concurrent chemoradiotherapy
* Ability to undergo MRI examination
* Signed informed consent

Exclusion Criteria:

* HPV-positive oropharyngeal carcinoma
* Contraindications for MRI
* Severe comorbidities preventing chemoradiotherapy
* Pregnancy or breastfeeding
* Inability to comply with study procedures

+Locations (1)

Facility	City	Country	Status
Institute of Oncology Ljubljana	Ljubljana	Slovenia