Ignite Creation Date:
2025-12-26 @ 11:45 AM
Ignite Modification Date:
2026-02-28 @ 5:32 AM
Study NCT ID:
NCT06592716
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-18
First Post:
2024-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Can Recurrence of Cancer in the Oropharynx be Detected by Blood Samples?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073890', 'term': 'Liquid Biopsy'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liquid biopsies, in form of blood samples from peripheral veins'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2024-09-06', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of HPV ddPCR', 'timeFrame': 'At enrollment and at 2 months after end treatment, and hereafter every 6 month for a minimum of 2 years, up to 3 years, or at suspicion of recurrence.', 'description': 'Sensitivity and specificity of the ddPCR ctHPV-DNA test compared to clinically or radiologically verified recurrence.'}], 'secondaryOutcomes': [{'measure': 'Time to recurrence by ctHPV-DNA', 'timeFrame': 'From enrollment and for minimum 2 years, up to 3 years, after treatment', 'description': 'Time to recurrence detected by ctHPV-DNA'}, {'measure': 'Time to recurrence by clinical/radiological examination', 'timeFrame': 'From enrollment and for minimum 2 years, up to 3 years, after treatment', 'description': 'Time to recurrence detected by clinical or radiological examination'}, {'measure': 'PET/CT', 'timeFrame': 'From enrollment and for minimum 2 years, up to 3 years, after treatment', 'description': 'Number of PET/CT scans without detectable recurrence'}, {'measure': 'Cancer fast-track referrals', 'timeFrame': 'From enrollment and for minimum 2 years, up to 3 years, after treatment', 'description': 'Number of referrals to Cancer Fast-track clinical investigations (conducted by an ENT specialist) without any detectable recurrences.'}, {'measure': 'Fear of Recurrence Questionnaire', 'timeFrame': 'at 2 months after treatment, and hereafter every 6 months for a minimum of 2 years, up to 3 years', 'description': 'Quality of Life (QoL) will be evaluated by the Fear of Recurrence Questionnaire (short form) - filled out by patients during follow-up visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV', 'HPV-DNA', 'Liquid biopsy', 'cell-free HPV-DNA', 'circulating HPV-DNA', 'circulating tumor HPV-DNA', 'ctHPV-DNA'], 'conditions': ['Oropharynx Cancer', 'Oropharynx Cancer, Metastatic', 'Oropharynx Cancer, Recurrent', 'Oropharyngeal Carcinoma', 'Oropharyngeal Squamous Cell Carcinoma (OPSCC)']}, 'descriptionModule': {'briefSummary': 'This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed HPV+ (and/or p16+) oropharyngeal squamous cell carcinoma\n* Above 18 years of age\n* Informed consent\n\nExclusion Criteria:\n\n* The patient does not speak or understand Danish\n* patients recieving palliative treatment'}, 'identificationModule': {'nctId': 'NCT06592716', 'briefTitle': 'Can Recurrence of Cancer in the Oropharynx be Detected by Blood Samples?', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Specificity and Sensitivity of Circulating HPV-DNA in Patients With Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'H-23071576'}, 'secondaryIdInfos': [{'id': 'p-2023-15163', 'type': 'OTHER', 'domain': 'Capital Region of Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Identify recurrence', 'description': 'The aim is to identify recurrence through longitudial analyses of circulating tumor HPV-DNA (ctHPV-DNA ) from blood samples.', 'interventionNames': ['Diagnostic Test: Liquid biopsy']}], 'interventions': [{'name': 'Liquid biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for ctHPV-DNA.', 'armGroupLabels': ['Identify recurrence']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Otorhinolaryngology, Head and Neck Surgery and Audiology', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Christian von Buchwald, Professor, MD, DMSci', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery and Audiology, Rigshospitalet'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Copenhagen University Hospital, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar, PhD, DMSci, Assistant Professor', 'investigatorFullName': 'Christian Grønhøj Larsen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}