Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-28 @ 4:59 AM
Study NCT ID:
NCT06337266
Status:
COMPLETED
Last Update Posted:
2024-03-29
First Post:
2024-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'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'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3622}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-22', 'studyFirstSubmitDate': '2024-03-19', 'studyFirstSubmitQcDate': '2024-03-22', 'lastUpdatePostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year OS', 'timeFrame': '5 years or 60 months', 'description': 'overall survival, death, survival with tumor, deletion'}, {'measure': '5-year DFS', 'timeFrame': '5 years or 60 months', 'description': 'Disease-free survival,Recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['oxidative stress', 'inflammation', 'Gastric adenocarcinoma', 'nomogram', 'recurrence risk'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'This study aimed to develop a novel Prognostic Oxidative Stress-Immune-Inflammatory Score (POSII Score) and introduce an innovative online calculator designed to predict long-term survival and assess the recurrence risk of gastric cancer (GC).', 'detailedDescription': 'From 2009 to 2020, this study analyzed GC patients underwent Radical Gastrectomy at three hospitals, dividing them into training, internal, and external validation cohorts. Twelve blood indicators were analyzed. The POSII Score was developed in the training cohort using the Least Absolute Shrinkage and Selection Operator (LASSO) technique. Additionally, two online nomogram calculators were created based on multivariate Cox regression within the training cohort and subsequently validated in internal and external validation cohorts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a multicenter, retrospective cohort investigation involving GC patients who underwent radical gastrectomy at the Fujian Medical University Union Hospital (FMUUH), the First Affiliated Hospital of Gannan Medical University (FAHGMU) and Quzhou Affiliated Hospital of Wenzhou Medical University (QAHWMU) between January 2009 and June 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:1) histopathologically diagnosed gastric adenocarcinoma, 2) undergoing radical gastrectomy for GC, 3) absence of tumor invasion into adjacent organs or distant metastasis, and 4) availability of complete laboratory data.\n\nExclusion Criteria: 1) non-adenocarcinoma gastric cancers, 2) gastric stump cancer, 3) receipt of neoadjuvant therapy, 4) a history of other malignancies, and 5) insufficient clinical data or follow-up information.'}, 'identificationModule': {'nctId': 'NCT06337266', 'briefTitle': 'A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Medical University'}, 'officialTitle': 'A Novel Online Calculator to Predict Long-term Survival and Recurrence Risk of Patients With Gastric Adenocarcinoma After Radical Gastrectomy : A Multicenter Real-world Study', 'orgStudyIdInfo': {'id': '2024KY246'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational', 'description': 'Cohort'}]}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Medical University Union Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}], 'overallOfficials': [{'name': 'Changming Huang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Medical University Union Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Chang-Ming Huang, Prof.', 'investigatorAffiliation': 'Fujian Medical University'}}}}