Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-03 @ 7:53 PM
Study NCT ID:
NCT02059668
Status:
COMPLETED
Last Update Posted:
2022-08-03
First Post:
2014-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, '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': 'if possible fresh-frozen tumor tissues, blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 588}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2014-02-10', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'local recurrence free survival', 'timeFrame': 'after 2 years'}], 'secondaryOutcomes': [{'measure': 'disease-free survival', 'timeFrame': 'after 2 years'}, {'measure': 'metastases-free survival', 'timeFrame': 'after 2 years'}, {'measure': 'overall survival', 'timeFrame': 'after 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['locally advanced head and neck cancer', 'biomarkers', 'definitive treatment', 'adjuvant treatment', 'radiochemotherapy'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'references': [{'pmid': '34332614', 'type': 'DERIVED', 'citation': 'Niu M, Combs SE, Linge A, Krause M, Baumann M, Lohaus F, Ebert N, Tinhofer I, Budach V, von der Grun J, Rodel F, Grosu AL, Multhoff G. Comparison of the composition of lymphocyte subpopulations in non-relapse and relapse patients with squamous cell carcinoma of the head and neck before, during radiochemotherapy and in the follow-up period: a multicenter prospective study of the German Cancer Consortium Radiation Oncology Group (DKTK-ROG). Radiat Oncol. 2021 Jul 31;16(1):141. doi: 10.1186/s13014-021-01868-5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this clinical research project is to validate the prognostic impact of potential biomarkers on loco-regional control of locally advanced head and neck cancer after definitive or adjuvant radiochemotherapy. The treatment is equal to the standard of care.\n\nPotential biomarkers from a previous retrospective study will be validated in this prospective study.', 'detailedDescription': 'Objectives:\n\nPrimary: Evaluation of local-regional recurrence- free survival after two years of patients with locally advanced head and neck cancer who received definitive or adjuvant radiochemotherapy.\n\nSecondary: Evaluation of disease-free -survival, metastases-free and overall survival after two years, of patients with locally advanced head and neck cancer.\n\nOutline: This is a multicenter observational study. The treatment is based on the center specific standard of care. The total dose will be between 69 and 73 Gy (definitive treatment) and 63 and 66 Gy (adjuvant treatment), the chemotherapy will be cisplatin- based.\n\nThe aim of the analysis is to validate the prognostic impact of potential biomarkers on loco-regional control. This will lead to the definition of risk groups and stratification of patients and will help to individualize radiotherapy prescription in future trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with the diagnosis locally advanced squamous cell carcinoma of the head and neck area', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary radiochemotherapy:\n\n* Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx\n* Stage III or IV without distant metastases\n* Patient is able to participate in regular tumor follow-up care\n* planned irradiation dose 69-72 Gy\n* planned overall treatment time 38-54 days\n* written informed consent of the patient\n* general condition according to WHO 0-2\n* planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 180 mg/m2 body surface, divided in several separately doses)\n\nAdjuvant radiochemotherapy:\n\n* Patients with locally advanced squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx\n* surgery, existence of one or more of the following risk factors for local recurrence:\n* extracapsular growth of a minimum of one lymph node metastasis\n* R1 resection\n* pT4 tumor and more than 3 affected lymph nodes\n* Patient is able to participate in regular tumor follow-up care\n* planned irradiation dose 63-66 Gy\n* planned overall treatment time 44-48 days\n* planned simultaneous chemotherapy with cisplatin (cumulative planned total dose minimum 200 mg/m2 body surface, divided in several separately doses)\n* written informed consent of the patient\n* general condition according to WHO 0-2\n* time since last surgery \\<56 days (8 weeks)\n\nExclusion Criteria:\n\nPrimary radiochemotherapy:\n\n* distant metastasis\n* contraindication against a cisplatin-based chemotherapy\n* planned total irradiation dose \\<69 Gy and \\>72 Gy\n* planned overall treatment time \\>54 days or \\<38 days\n* Patient is incapable of giving consent\n* previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas\n* other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient\n* tumor-independent diseases or conditions which reduce the survival probability of the patient to \\<2 years or which affect the follow-up over 2 years\n* no written informed consent\n* induction chemotherapy\n* pregnancy or lactation\n\nAdjuvant radiochemotherapy:\n\n* distant metastasis\n* contraindication against a cisplatin-based chemotherapy\n* planned total irradiation dose \\< 63 Gy or \\> 66 Gy\n* planned overall treatment time \\> 48 days or \\< 44 day\n* Patient is incapable of giving consent\n* previous radiotherapy in the head and neck area, if there is a risk for overlapping of the irradiation areas\n* other tumor diseases, which currently need a treatment or probably within the next two years or which influence the prognosis of the patient\n* tumor-independent diseases or conditions which reduce the survival probability of the patient to \\<2 years or which affect the follow-up over 2 years\n* no written informed consent\n* pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT02059668', 'acronym': 'HNprädBio', 'briefTitle': 'Observational Study on Biomarkers in Head and Neck Cancer (HNprädBio)', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Observational Study on Biomarkers in Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'STR- HNprädBio-2013'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Biomarker analyses head & neck cancer tissue, blood specimen', 'description': 'Validation of prognostic biomarkers for local tumor control in definitive and adjuvant treatment of head and neck cancer.', 'interventionNames': ['Biological: Biomarker analyses head & neck cancer tissue, blood specimen']}], 'interventions': [{'name': 'Biomarker analyses head & neck cancer tissue, blood specimen', 'type': 'BIOLOGICAL', 'description': 'For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.', 'armGroupLabels': ['Biomarker analyses head & neck cancer tissue, blood specimen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Prof. Anca-Ligia Grosu', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Prof. Jürgen Debus', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '72016', 'city': 'Tübingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Prof. Daniel Zips', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '81377', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Prof. Claus Belka', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '81675', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Prof. Stephanie Combs', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Prof. Claus Rödel', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Prof. Martin Stuschke', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Prof. Mechthild Krause', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Prof. Volker Budach', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '01067', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Praxis für Strahlentherapie im Krankenhaus Dresden - Friedrichstadt', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'overallOfficials': [{'name': 'Mechthild Krause, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dresden University of Technology, Universital Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Mechthild Krause', 'investigatorFullName': 'Mechthild Krause', 'investigatorAffiliation': 'Technische Universität Dresden'}}}}