Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-05 @ 9:58 AM
Study NCT ID:
NCT07407205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tumor Mutational Burden, Liquid Biopsy, Angiogenic Factors and DCE-MRI Perfusion in HPV-Negative Oropharyngeal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D000098543', 'term': 'Dynamic Contrast Enhanced Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2026-02-06', 'studyFirstSubmitQcDate': '2026-02-06', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy', 'timeFrame': 'Up to 6 months after completion of concurrent chemoradiotherapy'}, {'measure': 'Predictive Value of Biomarkers and DCE-MRI for Response to Chemoradiotherapy', 'timeFrame': 'Up to 6 months after completion of concurrent chemoradiotherapy', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV-negative', 'oropharyngeal cancer'], 'conditions': ['Oropharyngeal Squamous Cell Carcinoma', 'Oropharyngeal HPV Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed HPV-negative oropharyngeal squamous cell carcinoma\n* Planned treatment with concurrent chemoradiotherapy\n* Ability to undergo MRI examination\n* Signed informed consent\n\nExclusion Criteria:\n\n* HPV-positive oropharyngeal carcinoma\n* Contraindications for MRI\n* Severe comorbidities preventing chemoradiotherapy\n* Pregnancy or breastfeeding\n* Inability to comply with study procedures'}, 'identificationModule': {'nctId': 'NCT07407205', 'briefTitle': 'Tumor Mutational Burden, Liquid Biopsy, Angiogenic Factors and DCE-MRI Perfusion in HPV-Negative Oropharyngeal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'OI-HPVNEG-OPC-TMB-2019'}, 'secondaryIdInfos': [{'id': 'ARRS P3-0307', 'type': 'OTHER', 'domain': 'ARRS (Slovenian Research Agency)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Concurrent Chemoradiotherapy', 'description': '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.', 'interventionNames': ['Procedure: Concurrent Chemoradiotherapy', 'Diagnostic Test: Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)']}], 'interventions': [{'name': 'Concurrent Chemoradiotherapy', 'type': 'PROCEDURE', 'description': 'Standard-of-care concurrent chemoradiotherapy administered for HPV-negative oropharyngeal squamous cell carcinoma according to institutional treatment protocols.', 'armGroupLabels': ['Concurrent Chemoradiotherapy']}, {'name': 'Dynamic Contrast-Enhanced MRI Perfusion (DCE-MRI)', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Concurrent Chemoradiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}