Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-03-03 @ 10:04 AM
Study NCT ID:
NCT05839002
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}], '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'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "Patients' pathological sections"}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-20', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Five-year survival of patients', 'timeFrame': 'From surgery to the end of follow-up(at least 5 years later)', 'description': 'The survival of the patients was recorded by follow-up for five years after surgery.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasm, Esophagus', 'Neoplasm, Squamous Cell']}, 'referencesModule': {'references': [{'pmid': '40758472', 'type': 'DERIVED', 'citation': 'Huang X, Jiang D, Sun T, Zhou G, Zeng Z, Zhang S, Lin M, Fan H, Jian Z, You R, Liu F, Wu M, Xu W, Tang H, Hou Y, Tan L. Primary Tumour Burden Score: A Novel Staging Parameter for Oesophageal Squamous Cell Carcinoma after Neoadjuvant Chemoradiotherapy. Eur J Cardiothorac Surg. 2025 Sep 2;67(9):ezaf254. doi: 10.1093/ejcts/ezaf254.'}]}, 'descriptionModule': {'briefSummary': 'In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS).', 'detailedDescription': 'In this case-only study, the investigators try to define a novel staging parameter, the Primary Tumor Burden Score (PTBS), which will combine the proportion of residual primary tumor cells and pre-treatment pathological T stage (prepT stage). The investigators will also try to improve ypTNM stage by results of PTBS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ESCC undergoing nCRT at the Department of Thoracic Surgery, Zhongshan Hospital of Fudan University (training cohort), and the Department of Thoracic Surgery, Zhongshan Hospital Xiamen Branch (validation cohort), between January 2010 and February 2019 were reviewed. The inclusion criteria were (I) thoracic ESCC; (II) McKeown or Ivor-Lewis transthoracic approach; (III) locally advanced resectable tumor with cT3-4aNany staging treated with nCRT; (IV) no history of concomitant or prior malignancy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Neoadjuvant chemoradiotherapy and surgical resection of esophageal squamous cell carcinoma\n\nExclusion Criteria:\n\n* Patients receiving neoadjuvant chemoradiotherapy for esophageal squamous cell carcinoma without surgical resection'}, 'identificationModule': {'nctId': 'NCT05839002', 'briefTitle': 'Primary Tumor Burden Score:A Novel Staging Parameter for ESCC After nCRT', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'Primary Tumor Burden Score: A Novel Staging Parameter Superior to ypT-category for Esophageal Squamous Cell Carcinoma After Neoadjuvant Chemoradiotherapy', 'orgStudyIdInfo': {'id': 'CMISG1708'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Training cohort', 'description': 'Training cohort will be used to find the best calculation and cut-off values for PTBS in ESCC after nCRT.', 'interventionNames': ['Procedure: nCRT']}, {'label': 'Validation cohort', 'description': "The study's conclusion will be verified in Zhongshan Hospital Xiamen branch.", 'interventionNames': ['Procedure: nCRT']}], 'interventions': [{'name': 'nCRT', 'type': 'PROCEDURE', 'description': 'ESCC patients that recieved surgery and nCRT.', 'armGroupLabels': ['Training cohort', 'Validation cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident Physician', 'investigatorFullName': 'Xu Huang', 'investigatorAffiliation': 'Fudan University'}}}}