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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Standard-of-care concurrent chemoradiotherapy administered for HPV-negative oropharyngeal squamous cell carcinoma according to institutional treatment protocols.
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.
Institute of Oncology Ljubljana
Ljubljana, Slovenia
Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy
Time frame: Up to 6 months after completion of concurrent chemoradiotherapy
Predictive Value of Biomarkers and DCE-MRI for Response to 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.
Time frame: Up to 6 months after completion of concurrent chemoradiotherapy
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