Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT03416803
Status:
UNKNOWN
Last Update Posted:
2018-02-05
First Post:
2018-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2018-01-08', 'studyFirstSubmitQcDate': '2018-01-24', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2-year overall survival', 'timeFrame': 'The outcome measures are assessed up to 2 years.', 'description': 'The therapeutic effects are mainly evaluated by the 2-year overall survival.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymph Node Metastasis', 'Hepatocellular Carcinoma', 'Radiotherapy']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\n1. To further validate the predictive efficacy of our established microRNA prediction model of HCC lymph node metastasis.\n2. To establish a precise therapeutic mode of prophylactic radiation therapy in high-risk patients with HCC with lymph node metastasis under the guidance of a microRNA prediction model.', 'detailedDescription': 'First, screening out patients who underwent hepatic tumor resection and pathologically diagnosed as HCC .\n\nThen，performing the detection of miR-145, miR-31 and miR-92a by using the HCC lymph node metastasis microRNA correlation prediction model established in our previous study. The patients are judged as high risk of lymph node metastasis and low risk Patients, then high-risk patients under the condition of informed consent into the group, randomized into treatment group and control groups.\n\nLast, Patients enrolled in the treatment group were treated with radiotherapy and followed up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. patients underwent liver tumor resection and pathological diagnosis of HCC in our hospital.\n2. The tumor samples of these HCC patients were detected by in situ hybridization with miR-145, miR-31 and miR-92a. We used the previously established HCC lymph node metastasis microRNA prediction model to determine the patients with high-risk lymph node metastasis and low-risk patients at high risk Patients were randomly assigned into treatment group and control group with informed consent.\n3. HCC patients were not receive other anti-cancer treatment.\n4. Blood routine examination was normal.\n5. Child-Pugh grade A, normal liver and kidney function in the normal range (including ALT or ASL within 2.5 times the normal), WBC\\> 3 × 109 / L, Hb\\> 90g / L, PLT\\> 50 × 109 /\n6. HCC patients were not receive the history of upper abdominal radiotherapy.\n7. sign the informed consent.\n8. age 18-75 years old.\n9. KPS score 80-100 points.\n\nExclusion Criteria:\n\n1. accepted other anti-cancer treatment.\n2. Patients was determined to be low-risk lymph node metastasis by the pre-established HCC lymph node metastasis microRNA prediction model.\n3. blood and liver and kidney dysfunction.\n4. can not control the infection.\n5. at the same time the merger of other malignant tumors.\n6. while using other experimental drugs or to participate in other clinical trials.\n7. serious heart, lung, kidney disease.\n8. pregnant or lactating women.\n9. serious nervous system disease, can not clearly tell the treatment'}, 'identificationModule': {'nctId': 'NCT03416803', 'briefTitle': 'A Study of Individualized Radiotherapy Based on a Prediction Model of Lymph Node Metastasis in Hepatocellular Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Prediction of Lymph Node Metastasis in Hepatocellular Carcinoma and the Study of Individualized Radiotherapy', 'orgStudyIdInfo': {'id': 'ZS-LNM-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiotherapy', 'description': 'Patients in the experimental group, who were at high risk for lymph node metastasis, underwent radiotherapy in the lymphatic drainage area. Radiotherapy was started in lymphatic drainage areas about 1 month after HCC surgery. The range of radiotherapy was hepatic portal area, pancreas circumference, celiac trunk and abdomen Around the aortic lymph drainage area, the dose of radiation 45Gy, conventional segmentation.', 'interventionNames': ['Radiation: Radiotherapy']}, {'type': 'NO_INTERVENTION', 'label': 'Blank control', 'description': 'Patients in the control group , who were at high risk for lymph node metastasis，were followed up.'}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Radiotherapy', 'armGroupLabels': ['Radiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhaochong Zeng, Phd', 'role': 'CONTACT', 'email': 'zeng.zhaochong@zs-hospital.sh.cn', 'phone': '86-13817076800'}], 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhaochong Zeng, Phd', 'role': 'CONTACT', 'email': 'zeng.zhaochong@zs-hospital.sh.cn', 'phone': '13817076800'}, {'name': 'Zuolin Xiang, Phd', 'role': 'CONTACT', 'email': 'xiangzuolinmd@hotmail.com', 'phone': '13701816716'}], 'overallOfficials': [{'name': 'Zhongshan Hospital, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University, Shanghai,China'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}