Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-03-27 @ 9:38 AM
Study NCT ID:
NCT02975661
Status:
UNKNOWN
Last Update Posted:
2023-10-25
First Post:
2016-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 740}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-23', 'studyFirstSubmitDate': '2016-11-24', 'studyFirstSubmitQcDate': '2016-11-24', 'lastUpdatePostDateStruct': {'date': '2023-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease free survival (DFS)', 'timeFrame': 'Up to 2 years', 'description': 'Time from enrollment to tumor recurrence or death with any cause'}], 'secondaryOutcomes': [{'measure': 'Disease situation', 'timeFrame': 'Baseline period', 'description': 'Generally refers to tumor staging, classification, surgical methods, etc'}, {'measure': 'Quality of Life Score', 'timeFrame': 'Up to 2 years', 'description': 'Evaluate the quality of life of subjects during the trial by using the SF-36 scale.Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.'}, {'measure': 'Postoperative treatment methods', 'timeFrame': 'Up to 2 years', 'description': 'Generally including treatment plan, compliance, etc'}, {'measure': 'Concomitant medication', 'timeFrame': 'Up to 2 years', 'description': 'Other drugs (including chemical drugs, biological products, traditional Chinese patent medicines and simple preparations) taken by the subject in addition to the conventional research drugs during the clinical trial.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Cancer']}, 'descriptionModule': {'briefSummary': 'Registration of patients after gastrointestinal cancer radical surgery, including the information of treatments, recurrence \\& metastasis, adverse events,etc.', 'detailedDescription': 'This study adopts a multicenter, open, and registered research method, and plans to include 840 cases, including 360 cases in the Huaier Granule test group, 360 cases in the radiotherapy and chemotherapy control group, and 120 cases in the blank group. Using natural grouping, the registered objects are not pre grouped or queue divided, and the diagnosis, treatment, efficacy, and safety of gastrointestinal malignant tumor patients are accurately recorded under real conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients after gastrointestinal cancer radical surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with gastrointestinal cancer (stomach, colon or rectum);\n2. Patients who have received gastrointestinal cancer radical surgery within a month;\n3. Patients between 18 and 70 years old,no gender restriction;\n4. Patients volunteer to participate this study and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. No chemotherapy or combined radiation and chemotherapy indications；\n2. Unable to cooperate to complete related information collection;\n3. Participation in any other clinical trial within three months;\n4. Conditions that are considered not suitable for this study investigators.'}, 'identificationModule': {'nctId': 'NCT02975661', 'briefTitle': 'Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qidong Gaitianli Medicines Co., Ltd'}, 'officialTitle': 'Registry of Huaier Granule for Prevention of Recurrence and Metastasis of Gastrointestinal Cancer After Radical Surgery', 'orgStudyIdInfo': {'id': 'HE-201601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational 1', 'description': 'Huaier Granule'}, {'label': 'Observational 2', 'description': 'Radiotherapy or chemotherapy'}, {'label': 'Observational 3', 'description': 'treatment abandoned'}, {'label': 'Observational 4', 'description': 'Huaier Granule \\& Radiotherapy or chemotherapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '150086', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Harbin Medical University', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '161005', 'city': 'Qiqihar', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Qiqihar Medical College', 'geoPoint': {'lat': 47.33922, 'lon': 123.96154}}, {'zip': '021008', 'city': 'Hailar', 'state': 'Inner Mongolia', 'country': 'China', 'facility': "Hulunbuir People's Hospital", 'geoPoint': {'lat': 49.2, 'lon': 119.7}}, {'zip': '210012', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '225001', 'city': 'Yangzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': "Northern Jiangsu People's Hospital", 'geoPoint': {'lat': 32.39722, 'lon': 119.43583}}, {'zip': '130041', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'The Second Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '116001', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Affiliated Zhongshan Hospital of Dalian University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '116011', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Dalian Medical University', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '121012', 'city': 'Jinzhou', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of Jinzhou Medical University', 'geoPoint': {'lat': 41.10778, 'lon': 121.14167}}, {'zip': '110002', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Affiliated Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '030012', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospital", 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '030032', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Shanxi Bethune Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'overallOfficials': [{'name': 'Tongjun Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Hospital of Jilin University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qidong Gaitianli Medicines Co., Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}