Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-28 @ 4:27 AM
Study NCT ID:
NCT05126160
Status:
RECRUITING
Last Update Posted:
2021-11-18
First Post:
2021-11-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Score Based Radiomics in Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 494}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-07', 'studyFirstSubmitDate': '2021-11-07', 'studyFirstSubmitQcDate': '2021-11-07', 'lastUpdatePostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve (AUC)', 'timeFrame': 'Median follow-up time of 5 years for the whole group', 'description': 'The AUC of the immune score based radiomic staging system'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasopharyngeal Carcinoma']}, 'descriptionModule': {'briefSummary': 'In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Non-metastatic NPC patients receive radical radiotherapy with/without induction or concurrent chemotherapy. De novo metastatic NPC patients would receive at least 4 cycles of platinum-based therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.\n\nECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC \\>4\\*109/L, HGB\\>90G/L, and PLT\\>100\\*109/L. Written informed consent\n\nExclusion Criteria:\n\nContraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \\>1.5×ULN), or emotional disturbance.'}, 'identificationModule': {'nctId': 'NCT05126160', 'briefTitle': 'Immune Score Based Radiomics in Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang Cancer Hospital'}, 'officialTitle': 'Immune Score Based Radiomics in Nasopharyngeal Carcinoma (IMRAN Study)', 'orgStudyIdInfo': {'id': 'ZJCH-2021-NPC01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Immune Score Based Radiomics', 'type': 'DIAGNOSTIC_TEST', 'description': 'To establish an immune score based radiomic staging system for nasopharyngeal carcinoma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '430060', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiangpan Li', 'role': 'CONTACT', 'email': 'rm001227@whu.edu.cn'}, {'name': 'Xiangpan Li', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Qingqing Li', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Renmin Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '315000', 'city': 'Ningbo', 'state': 'Ningbo', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Pengrong Lou', 'role': 'CONTACT'}, {'name': 'Pengrong Lou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jianliang Zhou', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ningbo First Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '315000', 'city': 'Ningbo', 'state': 'Ningbo', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Miaozhen Lu', 'role': 'CONTACT', 'email': 'lmz2005@yeah.net'}, {'name': 'Miaozhen Lu', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yanping Bei', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Ningbo Medical Center Lihuili Hospital', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '325000', 'city': 'Wenzhou', 'state': 'Wenzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Changlin Zou', 'role': 'CONTACT', 'email': 'zcl19670115@163.com'}, {'name': 'Changlin Zou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raoying Xie', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The First Affiliated Hospital of Wenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaozhong Chen', 'role': 'CONTACT', 'email': 'cxzfyun@sina.com', 'phone': '571-88128202', 'phoneExt': '+86'}, {'name': 'Caineng Cao', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lei Wang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shuang Huang', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mengyun Qiang', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhejiang Cancer Hospital', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xiaozhong Chen', 'role': 'CONTACT', 'email': 'cxzfyun@sina.com', 'phone': '0571-88128202', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Xiaozhong Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology, Zhejiang Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Renmin Hospital of Wuhan University', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, {'name': 'Ningbo Medical Center Lihuili Hospital', 'class': 'OTHER_GOV'}, {'name': 'Ningbo No. 1 Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}