Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-05 @ 10:45 AM
Study NCT ID:
NCT02881918
Status:
UNKNOWN
Last Update Posted:
2018-01-26
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-tumor Specific Immune Response in Head and Neck Cancers
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'}]}, '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': 'Blood sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-24', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence or absence of spontaneous responses against tumor-associated antigens (TAA) according to tumor stage', 'timeFrame': 'day 0'}], 'secondaryOutcomes': [{'measure': 'Functional signature of T cell responses (polyfunctionality index of lymphocytes) according to tumor stage', 'timeFrame': 'day 0', 'description': 'Effector functions and phenotypes of T cells'}, {'measure': 'Number of CTCs according to tumor stage', 'timeFrame': 'day 0'}, {'measure': 'Polyfunctionality index of lymphocytes according to number of CTCs', 'timeFrame': 'day 0'}, {'measure': 'Disease free survival (survival without local or distant recurrence) according to Presence pr absence of CTCs at diagnosis', 'timeFrame': '2 years after diagnosis'}, {'measure': 'Disease free survival (survival without local or distant recurrence) according to Presence or absence of spontaneous responses against TAA', 'timeFrame': '2 years after diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose is the description of anti-tumor immune responses in general and according to clinical stage and disease free survival (DFS: survival without recurrence (local or distant)) in patients with Head \\& Neck Squamous Cell Carcinoma\n\nSecondary purposes are:\n\n* Study of relationship between anti-tumor immune response and qualitative (yes/no) and quantitative (number) presence of circulating tumor cells (CTCs);\n* Study of relationship between qualitative (yes/no) and quantitative (number) presence of CTCs and clinical stage as well as DFS\n* Study of relationship between anti-tumor immune response and clinical stage as well as DFS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Head \\& Neck Squamous Cell Carcinoma before any medical or surgical treatment specifically directed against cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with Head \\& Neck Squamous Cell Carcinoma after extension assessment, regardless of clinical stage (TNM UICC stage I-IV), before any medical or surgical treatment specifically directed against cancer (radiotherapy, surgery, chemotherapy or targeted therapy)\n* Consent to participate to the study, non-opposition\n* Affiliation to social security\n\nExclusion Criteria:\n\n* History of neoplasia, synchronous cancer, auto-immune disease, organ transplantation, chemotherapy\n* HIV infection\n* Corticotherapy during 15 days before blood sampling'}, 'identificationModule': {'nctId': 'NCT02881918', 'acronym': 'CORISAT', 'briefTitle': 'Anti-tumor Specific Immune Response in Head and Neck Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Anti-tumor Specific Immune Response in Head and Neck Cancers', 'orgStudyIdInfo': {'id': 'PSS2016 / CORISAT-GALLET/SR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'squamous cell carcinoma', 'description': 'Patients affected by Head \\& Neck Squamous Cell Carcinoma. Blood sample at diagnosis, before any antitumor treatment', 'interventionNames': ['Other: Blood sample']}], 'interventions': [{'name': 'Blood sample', 'type': 'OTHER', 'description': 'Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment', 'armGroupLabels': ['squamous cell carcinoma']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Besançon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier MAUVAIS', 'role': 'CONTACT'}], 'facility': "Service d'ORL - CHRU BESANCON", 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Dijon', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': "Service d'ORL - CHRU DIJON", 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Reims', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'facility': "Service d'ORL - CHRU REIMS", 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Philippe SCHULTZ', 'role': 'CONTACT'}], 'facility': "Service d'ORL - CHRU STRASBOURG", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Gilles DOLIVET', 'role': 'CONTACT'}], 'facility': 'Institut de Cancérologie Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'city': 'Vandœuvre-lès-Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrice GALLET', 'role': 'CONTACT'}], 'facility': 'Service ORL - Institut Louis Mathieu - CHRU NANCY', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Patrice GALLET', 'role': 'CONTACT', 'email': 'patrice.gallet@yahoo.fr', 'phone': '03 83 15 54 17', 'phoneExt': '+33'}, {'name': 'Marcelo DE CARVALHO', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Patrice GALLET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de ORL, Institut Louis Mathieu, CHRU de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}