Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT05706558
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2023-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective Review of Esophageal Cancer at MSKCC
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2023-01-23', 'studyFirstSubmitQcDate': '2023-01-23', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '. Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery)', 'timeFrame': 'Up to 2 years', 'description': 'Preoperative variables associated with overall survival and progression-free survival (measured from date of surgery) and the association between patient characteristics, neoadjuvant therapy, and postoperative morbidity.'}], 'secondaryOutcomes': [{'measure': 'Overall survival and progression-free survival (measured from date of surgery)', 'timeFrame': 'Up to 2 years', 'description': 'Postoperative outcomes stratified by the type of esophageal cancer surgery performed.'}, {'measure': 'Postoperative outcomes stratified by the time between neoadjuvant therapy and surgery (i.e., delayed or immediate).', 'timeFrame': 'Up to 2 years'}, {'measure': 'Survival outcomes stratified by treatment modality (i.e., definitive chemoradiation therapy or trimodality treatment).', 'timeFrame': 'Up to 2 years'}, {'measure': 'Survival outcomes stratified by use of adjuvant therapy (i.e., adjuvant therapy or no adjuvant therapy).', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal Cancer', 'Esophagus Cancer', 'Memorial Sloan Kettering Cancer Center', '16-1631'], 'conditions': ['Esophageal Cancer', 'Esophagus Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'Residual tumor at the proximal or distal margin after esophagectomy is a known prognostic factor for poor survival outcomes in patients with esophageal cancer; however, the significance of the circumferential resection margin (CRM) remains controversial. In this study, the investigators sought to evaluate the prognostic significance of the CRM in patients with esophageal cancer undergoing resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants undergoing esophagectomy for histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) during the period from 2000 to 2019.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed esophageal adenocarcinoma (EAC) or esophageal squamous cell carcinoma (ESCC) undergoing esophagectomy\n* Pathologic staged T3 tumors (pT3)\n\nExclusion Criteria:\n\n* Pathologic staged T0-2 (pT0-2) or T4 tumors (pT4)\n* Patients with histologic types other than EAC or ESCC, dysplasia or carcinoma in situ without tumor invasion,\n* Patients undergoing salvage esophagectomy\n* Evidence of distant metastatic disease\n* Patients with a positive proximal or distal margin'}, 'identificationModule': {'nctId': 'NCT05706558', 'briefTitle': 'Retrospective Review of Esophageal Cancer at MSKCC', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Retrospective Review of Esophageal Cancer at MSKCC', 'orgStudyIdInfo': {'id': '16-1631'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Circumferential resection margin (CRM)', 'description': 'Participants will have a diagnosis of esophageal carcinoma and residual tumor \\>1 mm from the CRM', 'interventionNames': ['Procedure: Esophagectomy']}, {'label': 'Circumferential resection margin (CRM)-close', 'description': 'Participants will have a diagnosis of esophageal carcinoma and residual tumor \\>0-1 mm from the CRM', 'interventionNames': ['Procedure: Esophagectomy']}, {'label': 'Circumferential resection margin (CRM)+', 'description': 'Participants will have a diagnosis of esophageal carcinoma and residual tumor at the surgical CRM', 'interventionNames': ['Procedure: Esophagectomy']}], 'interventions': [{'name': 'Esophagectomy', 'type': 'PROCEDURE', 'description': 'Esophagectomy', 'armGroupLabels': ['Circumferential resection margin (CRM)', 'Circumferential resection margin (CRM)+', 'Circumferential resection margin (CRM)-close']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniela Molena, MD', 'role': 'CONTACT', 'phone': '212-639-3870'}], 'facility': 'Memorial Sloan Kettering Cancer Center (All Protocol Activities)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Daniela Molena, MD', 'role': 'CONTACT', 'email': 'molenad@mskcc.org', 'phone': '212-639-3870'}, {'name': 'James Isbell, MD', 'role': 'CONTACT', 'email': 'isbellj@mskcc.org', 'phone': '212-639-6247'}], 'overallOfficials': [{'name': 'Daniela Molena, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}