Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-03-27 @ 7:27 PM
Study NCT ID:
NCT03053661
Status:
UNKNOWN
Last Update Posted:
2018-10-11
First Post:
2017-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Response Evaluation to Curative Conventional Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, peripheral blood mononuclear cells, tumor tissue (fresh frozen), formalin fixed paraffin embedded tumor tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2017-02-12', 'studyFirstSubmitQcDate': '2017-02-12', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of spontaneous tumor-specific immunity at baseline', 'timeFrame': 'baseline'}, {'measure': 'dynamics of tumor-specific immunity and immune modulatory cells during conventional treatment', 'timeFrame': '7-12 weeks (treatment phase)'}, {'measure': 'dynamics of tumor-specific immunity and immune modulatory cells during follow up', 'timeFrame': '12 months after end of treatment'}], 'secondaryOutcomes': [{'measure': 'overall survival at 3 years', 'timeFrame': 'baseline - 3 years'}, {'measure': 'progression free survival at 3 years', 'timeFrame': 'baseline - 3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Head and Neck Squamous Cell Carcinoma', 'cancer-specific immunity', 'cancer immunology', 'cancer-testis antigens', 'human papilloma virus', 'immune modulatory cells'], 'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '33336372', 'type': 'DERIVED', 'citation': 'von Witzleben A, Fehn A, Grages A, Ezic J, Jeske SS, Puntigam LK, Brunner C, Kraus JM, Kestler HA, Doescher J, Brand M, Theodoraki MN, Ottensmeier CH, Hoffmann TK, Schuler PJ, Laban S. Prospective longitudinal study of immune checkpoint molecule (ICM) expression in immune cell subsets during curative conventional therapy of head and neck squamous cell carcinoma (HNSCC). Int J Cancer. 2021 Apr 15;148(8):2023-2035. doi: 10.1002/ijc.33446. Epub 2020 Dec 30.'}]}, 'descriptionModule': {'briefSummary': 'The IRECT trial is a non-interventional, prospective clinical trial using modern immune monitoring techniques over the course of the standard of care for HNSCC. The dynamics of host/tumor immune interactions during the conventional standard treatment will be analyzed to find the most promising target antigen and to develop a strategy how and when specific immunotherapy should be added to the current treatment schedule.\n\nThe results from this trial will help to understand how state of the art treatment can be complemented using cancer-testis antigen specific vaccines and immune-modulating drugs to improve the outcome of head and neck cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'stage III-IVa/b treatment-naive head and neck squamous cell carcinoma patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* newly diagnosed patients with stage III-IVa/b head and neck squamous cell carcinoma\n* fit for treatment with curative intent\n* conventional primary treatment\n* primary surgical treatment\n* primary radiotherapeutic treatment\n* informed consent\n* \\>18 years of age\n* sufficient contraception\n\nExclusion Criteria:\n\n* distant metastasis at baseline\n* severe concomitant disease compromising curative treatment\n* previously diagnosed other malignant diseases\n* active immunosuppressive therapy\n* known immune defect\n* pregnancy\n* anemia requiring treatment at study entry (\\<9g/dl)'}, 'identificationModule': {'nctId': 'NCT03053661', 'acronym': 'IRECT-01', 'briefTitle': 'Immune Response Evaluation to Curative Conventional Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Immune Response Evaluation to Curative Conventional Therapy of Stage III/IV Head and Neck Squamous Cell Carcinoma Patients', 'orgStudyIdInfo': {'id': 'IRECT-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'primary surgery + adj. C)RT', 'description': 'treatment naive patients to be treated by conventional primary surgery followed by adjuvant (chemo-)radiotherapy with curative intent'}, {'label': 'primary chemoradiation', 'description': 'treatment naive patients to be treated by conventional primary chemoradiotherapy with curative intent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head & Neck Cancer Lead, Interdisciplinary Oncologic Outpatient Unit', 'investigatorFullName': 'Simon Laban, MD', 'investigatorAffiliation': 'University of Ulm'}}}}