Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 5:55 AM
Study NCT ID:
NCT06241066
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2024-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'ACTUAL', 'count': 359}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2024-01-25', 'studyFirstSubmitQcDate': '2024-02-02', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OS', 'timeFrame': 'The time from treatment to death or last follow-up, assessed up to 100 months.', 'description': 'Overall Survival'}, {'measure': 'DFS', 'timeFrame': 'The time from treatment to the first recurrence or last follow-up, assessed up to 100 months.', 'description': 'Disease-free Survival'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Retrospective analysis of the presence and maturity of tertiary lymphoid structures in pathological sections of patients with esophageal squamous cell carcinoma after surgical treatment. Pay attention to the overall survival and disease free survival of these esophageal squamous cell carcinoma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients pathologically confirmed esophageal squamous cell carcinoma(ESCC) who underwent complete surgical resection at Tianjin Medical University Cancer Hospital between 2014 and 2021', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Pathologically diagnosed as esophageal squamous cell carcinoma; 2. Surgery for esophageal cancer; 3. Complete medical records;\n\nExclusion Criteria:\n\n* Patients with a previous history of malignant tumor'}, 'identificationModule': {'nctId': 'NCT06241066', 'briefTitle': 'The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Tianjin Medical University Cancer Institute and Hospital'}, 'officialTitle': 'The Prognostic Value of Tertiary Lymphatic Structure in Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'bc2023192'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgery alone group', 'description': 'Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection without any prior treatment are included in this group. These patients had not been diagnosed with any other cancer. Finally, 96 patients were included.', 'interventionNames': ['Other: no-Intervention']}, {'label': 'Neoadjuvant chemotherapy group', 'description': 'Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 89 patients were included.', 'interventionNames': ['Other: no-Intervention']}, {'label': 'Neoadjuvant chemotherapy combined with immunotherapy group', 'description': 'Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with immunotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 81 patients were included.', 'interventionNames': ['Other: no-Intervention']}, {'label': 'Neoadjuvant chemotherapy combined with radiotherapy group', 'description': 'Patients who were diagnosed with esophageal squamous cell carcinoma and underwent esophageal squamous cell carcinoma resection, and underwent routine chemotherapy combined with radiotherapy before surgery were included in this group. These patients were not diagnosed with any other cancers Finally, 93 patients were included.', 'interventionNames': ['Other: no-Intervention']}], 'interventions': [{'name': 'no-Intervention', 'type': 'OTHER', 'description': 'no-Intervention', 'armGroupLabels': ['Neoadjuvant chemotherapy combined with immunotherapy group', 'Neoadjuvant chemotherapy combined with radiotherapy group', 'Neoadjuvant chemotherapy group', 'Surgery alone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Wencheng Zhang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Medical University Cancer Institute and Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tianjin Medical University Cancer Institute and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}