Oropharyngeal Squamous Cell CarcinomaNCT07407205
Tumor Mutational Burden, Liquid Biopsy, Angiogenic Factors and DCE-MRI Perfusion in HPV-Negative Oropharyngeal Cancer
A study testing Concurrent Chemoradiotherapy and Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI) in people with Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal HPV Squamous Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal HPV Squamous Cell Carcinoma
- What is being tested?
- Concurrent Chemoradiotherapy and Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSlovenia
- Study dates
- 10 Jun 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma
- Planned treatment with concurrent chemoradiotherapy
- Ability to undergo MRI examination
- Signed informed consent
Who cannot join
- HPV-positive oropharyngeal carcinoma
- Contraindications for MRI
- Severe comorbidities preventing chemoradiotherapy
- Pregnancy or breastfeeding
- Inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Concurrent Chemoradiotherapy, Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)
- Keywords
- HPV-negative, oropharyngeal cancer
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent ChemoradiotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Concurrent Chemoradiotherapy; Diagnostic Test: Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy
Measured: 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.
Measured: Up to 6 months after completion of concurrent chemoradiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Jun 2019
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Oncology Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407205
- Sponsor's protocol ID
- OI-HPVNEG-OPC-TMB-2019
- Other IDs
- ARRS P3-0307
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07407205
- Acronym / sponsor ID
- OI-HPVNEG-OPC-TMB-2019
- Keywords
- HPV-negative, oropharyngeal cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Oncology LjubljanaUniversity, hospital or other
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma
- Planned treatment with concurrent chemoradiotherapy
- Ability to undergo MRI examination
- Signed informed consent
Key exclusion criteria (5 listed)
- HPV-positive oropharyngeal carcinoma
- Contraindications for MRI
- Severe comorbidities preventing chemoradiotherapy
- Pregnancy or breastfeeding
- Inability to comply with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent ChemoradiotherapyStandard-of-care concurrent chemoradiotherapy administered for HPV-negative oropharyngeal squamous cell carcinoma according to institutional treatment protocols. | Procedure or surgery | Concurrent Chemoradiotherapy |
| Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)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. | Diagnostic test | Concurrent Chemoradiotherapy |
Primary outcome
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent Chemoradiotherapy and Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI) in people with Oropharyngeal Squamous Cell Carcinoma and Oropharyngeal HPV Squamous Cell Carcinoma, run by Institute of Oncology Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy (time frame: Up to 6 months after completion of concurrent chemoradiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.