Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-27 @ 11:55 AM
Study NCT ID:
NCT06869356
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2025-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008207', 'term': 'Lymphatic Metastasis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1291}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2025-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2025-01-21', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of lymph node metastasis', 'timeFrame': 'periprocedurally'}], 'secondaryOutcomes': [{'measure': 'Accuracy, specificity, and sensitivity of gold standards', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'Postoperative histopathology of ultrasonic gastroscopy for tumor invasion depth, abdominal and pelvic enhanced computed tomography (CT) scan for LNM, pathological biopsy for tumor differentiation, and auxiliary examination for TNM staging.'}, {'measure': 'Logistic regression model', 'timeFrame': 'Periprocedural', 'description': 'To explore the corresponding logistic regression model, postoperative histopathological examination for LNM, depth of infiltration, and degree of differentiation are evaluated in the univariate analysis. Variables with statistical significance in the univariate analysis are examined in the multivariate analysis.'}, {'measure': 'Complications', 'timeFrame': 'Periprocedural', 'description': 'Postoperative complications classified as higher than Grade II'}, {'measure': 'Five-year relapse-free survival rate', 'timeFrame': 'through study completion, an average of 5 year', 'description': 'The time interval from the date of operation to the detection of tumor recurrence within 5 years is recorded.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Expanded indications for ESD', 'Lymph node metastasis', 'Staging diagnosis scheme', 'Chinese population'], 'conditions': ['Gastric Cancer Stage']}, 'descriptionModule': {'briefSummary': "Background: The main treatment methods for early gastric cancer (EGC) include endoscopic submucosal dissection (ESD) and radical gastrectomy. However, appropriate treatment for patients who exceed the absolute indications for ESD remains unestablished. In China, evidence-based medicine for the expanding indications of ESD and accurate diagnostic staging for EGC patients are lacking. Thus, clinical studies involving Chinese patients with EGC are necessary to select appropriate treatment options and promote China's expanded indications for ESD and diagnostic staging scheme.\n\nMethods: This is a multicenter, ambispective, observational, open-cohort study that is expected to enroll 554 patients with EGC. The study was launched in May 2018 and is scheduled to end in March 2022. All enrolled patients should meet the inclusion criteria. Case report forms and electronic data capture systems are used to obtain clinical data, which includes demographic information, results of perioperative blood- and auxiliary examinations, surgical information, results of postoperative pathology, and the outcomes of postoperative recovery and follow-up. Patients are followed up every 6 months after surgery for a minimum of 5 years. The primary endpoint is the rate of lymph node metastasis (LNM), whereas the secondary endpoints include the following: consistency, sensitivity, and specificity of the results of preoperative examinations and postoperative pathology cut off values for LNM; logistic regression model of expanded indications for ESD; and incidence of postoperative complications within the 30-day and 5-year relapse-free survival rates.", 'detailedDescription': 'This study will explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC and will introduce a related staging procedure and examination scheme that is appropriate for China. Ethical approval was obtained from all participating centers. The findings are expected to be disseminated through publications or presentations and will facilitate clinical decision-making in EGC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study aims to explore and evaluate expanded indications for ESD that match the characteristics of the Chinese population in patients with EGC, and to introduce a staging procedure and examination scheme for EGC that is appropriate for China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients aged 18-75 years (regardless of sex). Patients with tumor diameter \\> 30 mm, ulceration (UL)(+), and differentiated mucosal carcinoma (T1a).\n\nPatients with tumor diameter \\> 30 mm and differentiated, submucosal invasion depth \\< 500 μm (T1b SM1).\n\nPatients with tumor diameter ≤ 30 mm and differentiated submucosal carcinoma (T1b).\n\nPatients with tumor diameter ≤ 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter \\> 20 mm, UL(-), and undifferentiated (T1a). Patients with tumor diameter ≤ 30 mm, UL(+), and undifferentiated (T1a). Patients with tumor diameter \\> 30 mm, UL(+), and undifferentiated (T1a).\n\nExclusion Criteria:\n\nPatients with gastric stump cancer. Patients with recurrent gastric cancer. Patients with multiple primary malignant tumors.'}, 'identificationModule': {'nctId': 'NCT06869356', 'briefTitle': 'Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Friendship Hospital'}, 'officialTitle': 'Expanded Indications of Endoscopic Submucosal Dissection for Early Gastric Cancer in China: a Multicenter, Ambispective, Observational, Open-cohort Study', 'orgStudyIdInfo': {'id': 'ChiCTR1800016084'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'D2 gastrectomy', 'description': 'Under the requirement of the guideline for laparoscopic gastrectomy for gastric cancer (2016 edition), laparoscopic radical gastrectomy is performed in patients.', 'interventionNames': ['Procedure: D2 gastrectomy']}], 'interventions': [{'name': 'D2 gastrectomy', 'type': 'PROCEDURE', 'description': 'Under the requirement of the guideline for laparoscopic gastrectomy for gastric cancer (2016 edition), laparoscopic radical gastrectomy is performed in patients.', 'armGroupLabels': ['D2 gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100050', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Friendship hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Friendship Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}