Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-02-27 @ 10:34 AM
Study NCT ID:
NCT02916368
Status:
UNKNOWN
Last Update Posted:
2016-09-28
First Post:
2016-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2016-09-26', 'studyFirstSubmitQcDate': '2016-09-26', 'lastUpdatePostDateStruct': {'date': '2016-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Squamous Cell']}, 'descriptionModule': {'briefSummary': 'Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors .Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.', 'detailedDescription': 'Head and neck Squamous Cell Carcinoma (HNSCC) is one of the most common head and neck malignant tumors. Investigators found that several patients with early TNM stage and poor differentiated HNSCC had poor prognosis, yet someone with advanced TNM stage and well differentiated HNSCC had good prognosis. Hence, Investigators suggested that prognosis factors and survival rates probably related to the differentiation of HNSCC, and prognosis factor of poorly differentiated HNSCC were rare discussed and controversy. Investigating the prognostic factors of poorly differentiated HNSCC is undoubtedly crucial.\n\nAbout this study ,inclusion criteria were the following parts:\n\nthe patients of poor differentiated HNSCC ; T1-4aN0-2M0; pathological examination: poor differentiated squamous cell carcinoma; initial treatment(primary, without surgery, radiotherapy and chemotherapy); range:18-70 years old; KPS\\>80; hemogram and the function of main organ such as heart, lung, liver and kidney were normal; having the endoscopy, CT and MRI before formed into different groups; sign the informed consent file, good compliance.\n\nAND the exclusion criteria were:\n\nuncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis; serious and uncontrollable infection; main organ system failure (including heart ,lung ,liver and kidney); reject training; high and moderate differentiated squamous cell carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The population were those patients with poor differentiated HNSCC from 18 to 70 years old,be in the stage of T1-4aN0-2M0 and the pathological examination shows poor differentiated squamous cell carcinoma ,also be willing take part in this study of treatment. The function of their main organ such as heart, lung, liver and kidney were normal and having the endoscopy, CT and MRI before formed into different groups.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of poor differentiated HNSCC ;\n* Patients within the stage of T1-4aN0-2M0;\n* The pathological examination of the patients show poor differentiated squamous cell carcinoma;\n* Patients with initial treatment(primary, without surgery, radiotherapy and chemotherapy);\n* 18-70 years old;\n* KPS\\>80;\n* Hemogram and the function of main organ such as heart, lung, liver and kidney were normal\n* Having the endoscopy, CT and MRI Signed the informed consent file, good compliance.\n\nExclusion Criteria:\n\n* Uncontrollable epileptic seizure, disorder of central nervous system or unconsciousness cause by psychosis;\n* Serious and uncontrollable infection;\n* Main organ system failure (including heart ,lung ,liver and kidney); reject training;\n* High and moderate differentiated squamous cell carcinoma'}, 'identificationModule': {'nctId': 'NCT02916368', 'briefTitle': 'The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tongren Hospital'}, 'officialTitle': 'The Clinical Study of the Poorly Differentiated Head and Neck Squamous Cell', 'orgStudyIdInfo': {'id': 'PDHNSCC-01609'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with surgery'}, {'label': 'with chemotherapy or radiotherapy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Capital Medical University', 'investigatorFullName': 'Zhigang Huang', 'investigatorAffiliation': 'Beijing Tongren Hospital'}}}}