Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2025-12-25 @ 7:19 PM
Study NCT ID:
NCT04996732
Status:
RECRUITING
Last Update Posted:
2021-08-09
First Post:
2021-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006760', 'term': 'Hospitalization'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2041-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-02', 'studyFirstSubmitDate': '2021-08-02', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2040-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '15 years', 'description': 'Death from any cause'}], 'secondaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '15 years', 'description': 'the time from treatment to recurrence of cancer, second primary cancer or death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Survivorship'], 'conditions': ['Neoplasms', 'Survival', 'Surgery', 'Radiotherapy', 'Drug Therapy']}, 'descriptionModule': {'briefSummary': 'Real-world studies on long-term prognosis in patients who underwent anti-tumor treatments during hospitalization from a hospital-based cancer registry in china.', 'detailedDescription': 'This is a single-center continuous enrollment cohort study. The overall survival and disease-free survival of patients with malignant tumors in the target tumor hospital undergoing surgery, radiotherapy, chemotherapy, and immunotherapy were observed. Follow-up methods include medical records review, telephone call interview, and data linkage to the related provincial death certificate registries. This study will provide real world data-sets for researches on long-term survival and prognosis of cancer patients, and expend exploration on the cancer survival determinants both from clinical and social-economic prospective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who completed tumor treatment (including surgery, radiotherapy, chemotherapy, immunotherapy, etc.) due to malignant tumors based on preoperative or intraoperative evaluation in Fudan University Shanghai Cancer Center during the study period.\n\nExclusion Criteria:\n\n* Patients who have not been treated during hospitalization;\n* Patients with non-malignant tumors.'}, 'identificationModule': {'nctId': 'NCT04996732', 'briefTitle': 'Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Single-institutional Cancer Registry', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Studies on Long-term Survivorship of Discharged Patients With Malignant Tumor Based on Fudan University Shanghai Cancer Center Registry（FUCaRe）', 'orgStudyIdInfo': {'id': 'YF-2021-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All Cancers', 'description': 'subgroups according to cancer sites', 'interventionNames': ['Procedure: hospitalization']}], 'interventions': [{'name': 'hospitalization', 'type': 'PROCEDURE', 'description': 'Including various treatments such as surgery, radiotherapy, chemotherapy and immunotherapy during hospitalization', 'armGroupLabels': ['All Cancers']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Zheng, Dr.', 'role': 'CONTACT', 'email': 'zhengying@fudan.edu.cn', 'phone': '+8618121299522'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ying Zheng, Dr.', 'role': 'CONTACT', 'email': 'zhengying@fudan.edu.cn', 'phone': '+8618121299522'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cancer Prevention Department, Fudan University Shanghai Cancer Center', 'investigatorFullName': 'Ying Zheng', 'investigatorAffiliation': 'Fudan University'}}}}