Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04567056
Status:
RECRUITING
Last Update Posted:
2025-02-07
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Specific Methylation Profiles in HNSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-05', 'studyFirstSubmitDate': '2020-09-23', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy', 'timeFrame': 'At diagnosis', 'description': 'How accurate can the methylation profiles diagnose the head and neck squamous cell carcinoma'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head and neck cancer', 'Squamous Cell carcinoma', 'Methylation', 'DNA'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'In the study, N-20190047, the investigators aim to define specific methylation patterns in a group of patients with head and neck squamous cell carcinomas.\n\nWith this study the investigators aim to validate these findings in a larger cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer group:\n\nPatients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery with suspicion of, or with already verified Head and neck squamous cell carcinoma. Only patients with verified squamous cell carcinoma after diagnostic work-up will be eligible.\n\nControl group:\n\nPatients referred from the region of Northern Denmark to the Department of Otorhinolaryngology - Head and Neck Surgery for evaluation or treatment, but without suspected or verified malignancy of the head and neck.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Cancer group:\n\nInclusion Criteria:\n\n* Written informed consent\n* Verified head and neck squamous cell carcinoma\n\nExclusion Criteria:\n\n* Other active cancer\n* Uncontrolled comorbidity\n* Unable to give informed consent\n\nControl group:\n\nInclusion Criteria:\n\n* Written informed consent\n* Normal ENT-examination\n\nExclusion Criteria:\n\n* Other active cancer\n* Uncontrolled comorbidity\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT04567056', 'briefTitle': 'Specific Methylation Profiles in HNSCC', 'organization': {'class': 'OTHER', 'fullName': 'Aalborg University Hospital'}, 'officialTitle': 'Validation of Specific Methylation Profiles Ind Head and Neck Cancer - a Cohort Study', 'orgStudyIdInfo': {'id': 'N-20190047-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cancer group', 'description': 'Patients with verified head and neck squamous cell carcinomas', 'interventionNames': ['Diagnostic Test: Blood sample']}, {'label': 'Control group', 'description': 'Matched control group without active or earlier cancer and a normal ENT examination.', 'interventionNames': ['Diagnostic Test: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'A separate blood sample will be taken for methylation-analyses', 'armGroupLabels': ['Cancer group', 'Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Danstrup, M.D', 'role': 'CONTACT', 'email': 'csd@rn.dk', 'phone': '+45 23800598'}], 'facility': 'Department of Otolaryngology - Head and Neck Surgery', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}], 'centralContacts': [{'name': 'Christian Danstrup, M.D.', 'role': 'CONTACT', 'email': 'csd@rn.dk', 'phone': '+45 23800598'}, {'name': 'Michael Gaihede, Professor', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Michael Gaihede, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Aalborg University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aalborg University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, M.D.', 'investigatorFullName': 'Christian Sander Danstrup', 'investigatorAffiliation': 'Aalborg University Hospital'}}}}