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

NCT07407205 | Active Not Recruiting

• 2 other identifiers: OI-HPVNEG-OPC-TMB-2019ARRS P3-0307
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Squamous Cell Carcinoma; Oropharyngeal HPV Squamous Cell Carcinoma

Keywords

HPV-negative; oropharyngeal cancer

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Up to 6 months after completion of concurrent chemoradiotherapy

Study Arms (1)

Concurrent Chemoradiotherapy

EXPERIMENTAL

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.

Procedure: Concurrent Chemoradiotherapy; Diagnostic Test: Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)

Interventions

Concurrent Chemoradiotherapy PROCEDURE

Standard-of-care concurrent chemoradiotherapy administered for HPV-negative oropharyngeal squamous cell carcinoma according to institutional treatment protocols.

Concurrent Chemoradiotherapy

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.

Concurrent Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Oncology Ljubljana: lead

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms

Interventions

Chemoradiotherapy; Dynamic Contrast Enhanced Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy; Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: June 10, 2019
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)