Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-23 @ 12:19 PM
Study NCT ID:
NCT02908204
Status:
UNKNOWN
Last Update Posted:
2016-09-21
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-19', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-16', 'lastUpdatePostDateStruct': {'date': '2016-09-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '3 years after treatment'}], 'secondaryOutcomes': [{'measure': 'Recurrence rate', 'timeFrame': '3 years after treatment'}, {'measure': 'Short-term complications incidence rate', 'timeFrame': '30 days after treatment'}, {'measure': 'Long-term complications incidence rate', 'timeFrame': '3 years after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['superficial esophageal squamous cell carcinoma', 'efficacy', 'survival'], 'conditions': ['Esophageal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Tumor is the primary public health problem and the incidence of esophageal cancer showed the increasing trend in the past thirty years. According to the statistics in 2015, the new onset of esophageal cancer is about 477,900 yearly. The mainly pathologic type of esophageal cancer in China is esophageal squamous cell carcinomas, which accounts for more than 90% of patients in China. With the development of endoscopic technics, more and more patients choose to receive the endoscopic procedure rather than traditional surgery. However, the long-term efficacy and outcomes of patients with superficial esophageal squamous cell carcinoma received different interventions remained unclear. Thus, investigators aim to conduct a multi-center retrospective study to investigate the long term outcomes of superficial esophageal squamous cell carcinoma patients receiving endoscopic treatment and surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with superficial esophageal squamous cell carcinoma underwent endoscopic treatment or traditional surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients received endoscopic treatment because of the superficial esophageal disease and had the pathologic diagnosis of squamous cell carcinoma.\n\nExclusion Criteria:\n\n* Combined with other severe disease\n* With a history of esophageal surgery\n* Combined with other malignant disease'}, 'identificationModule': {'nctId': 'NCT02908204', 'briefTitle': 'Long-term Outcomes of Superficial Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Long-term Outcomes After Treatment for Superficial Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'SGZAHGX'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic treatment', 'description': 'Patients underwent endoscopic treatment including Endoscopic Mucosal Resection (EMR), Endoscopic Submucosal Dissection (ESD), Multiband Mucosectomy (MBM), Endoscopic Mucosal Band Ligation(EMBL) and so on.'}, {'label': 'Traditional surgery', 'description': 'Patients underwent traditional surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoquan HUANG, M.D.', 'role': 'CONTACT', 'email': 'huangxiaoquan1010@aliyun.com', 'phone': '18801733835'}], 'facility': 'Zhongshan Hospital,', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Shiyao CHEN, PhD', 'role': 'CONTACT', 'email': 'chen.shiyao@zs-hospital.sh.cn', 'phone': '13601767310'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School', 'class': 'OTHER'}, {'name': 'Tongji Hospital', 'class': 'OTHER'}, {'name': 'The affiliated Hospital of Shihezi University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Shiyao Chen', 'investigatorAffiliation': 'Shanghai Zhongshan Hospital'}}}}