Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-29 @ 1:09 PM
Study NCT ID:
NCT03065257
Status:
UNKNOWN
Last Update Posted:
2017-04-25
First Post:
2017-02-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Resection Multicenter Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'C562464', 'term': 'Polyposis, Gastric'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003111', 'term': 'Colonic Polyps'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-21', 'studyFirstSubmitDate': '2017-02-16', 'studyFirstSubmitQcDate': '2017-02-22', 'lastUpdatePostDateStruct': {'date': '2017-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with successful completion of treatment', 'timeFrame': '30 days post procedure', 'description': 'Number of participants with successful completion of treatment'}], 'primaryOutcomes': [{'measure': 'Number of participants with reduction in clinical symptoms', 'timeFrame': '6 months from procedure', 'description': 'To assess resolution of symptoms of all Endoscopic resection procedures at 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '30 days post procedure', 'description': 'Number of subjects with Adverse Events; Type, frequency and intensity of adverse events within 30 days of procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['EMR', 'ESD', 'Resection', 'STER', 'EFTR', 'Submucosal dissection', 'Endoscopic resection'], 'conditions': ['Gastrointestinal Neoplasms', 'Gastrointestinal Disease', 'Gastric Cancer', 'Gastric Neoplasm', 'Gastric Polyp', 'Esophageal Neoplasms', 'Duodenal Neoplasms', 'Duodenal Polyp', 'Stomach Neoplasm', 'Stomach Polyp', 'Neoplasms', 'Colon Polyp', 'Colon Neoplasm']}, 'descriptionModule': {'briefSummary': 'This is a retrospective and prospective multicenter registry to collect long-term data (1 year) on patients who have or will undergo Endoscopic resection such as EMR, ESD, EFTR, STER, etc. within the gastrointestinal tract for endoscopic treatment of early gastrointestinal neoplasms involving the resection of the superficial layers, mucosa and submucosa, of the tract wall.\n\nSubjects will be consented for medical chart review.\n\nThe purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).\n\nThe registry will evaluate efficacy, technical feasibility, clinical outcome, safety profile and overall clinical management through medical chart review. The procedures the investigators are evaluating are all clinically indicated and will not be prescribed to someone to participate in this registry study.', 'detailedDescription': 'Endoscopic resection can be an appropriate approach in early neoplasms, challenging adenomas or sub-epithelial lesions. Endoscopic resection can be considered as a less invasive approach than surgery. Moreover, endoscopic resection can be available to patients who are ineligible for surgery or who have refused more aggressive surgical intervention.\n\nThe study investigators would collect data on a large sample size of subjects undergoing various endoscopic resection procedures such as EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection, and EFTR (Endoscopic full-thickness resection). Clinical metrics will be recorded including procedure times, length of follow-up, specific tumor characteristics, resection method, pathology results, procedural complications, additional therapy required, and disease-free survival time.\n\nCurrently, there is limited multi-center data on endoscopic resection outcomes in western populations.\n\nEvaluation of these measurement would help the investigators compare them to conventional treatment modalities within current tertiary facilities; and consequently help the investigators identify appropriate treatment techniques and improve clinical management of patients at WCMC-NYPH.\n\nThe purpose of this retrospective and prospective registry is to assess long term data on efficacy, safety and clinical outcome of Endoscopic Resection within the gastrointestinal tract (1 year).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing Endoscopic resection procedures as part of their clinically indicated care', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient who is considering undergoing endoscopic resection within 6 months, or has undergone clinically indicated endoscopic resection within the past 6 months\n* Above or equal to 18 years of age.\n\nExclusion Criteria:\n\n* Any patient who has not undergone or will undergo endoscopic resection\n* Below 18 years of age.'}, 'identificationModule': {'nctId': 'NCT03065257', 'briefTitle': 'Endoscopic Resection Multicenter Registry', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Endoscopic Resection: A Retrospective and Prospective Multicenter Registry', 'orgStudyIdInfo': {'id': '1701017930'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic Resection', 'description': 'Patients undergoing Endoscopic Resection', 'interventionNames': ['Procedure: Endoscopic Resection']}], 'interventions': [{'name': 'Endoscopic Resection', 'type': 'PROCEDURE', 'description': 'Any Endoscopic resection for Gastrointestinal disorders including neoplasms.', 'armGroupLabels': ['Endoscopic Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michel Kahaleh, MD', 'role': 'CONTACT', 'email': 'mik9071@med.cornell.edu', 'phone': '646-962-4797'}, {'name': 'Monica R Gaidhane, MPH', 'role': 'CONTACT', 'email': 'mog2012@med.cornell.edu', 'phone': '646-962-4796'}], 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Michel Kahaleh, MD', 'role': 'CONTACT', 'email': 'mik9071@med.cornell.edu', 'phone': '646-962-4797'}, {'name': 'Monica R Gaidhane, MPH', 'role': 'CONTACT', 'email': 'mog2012@med.cornell.edu', 'phone': '646-962-4796'}], 'overallOfficials': [{'name': 'Michel Kahaleh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD Sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Endoscopy', 'investigatorFullName': 'Michel Kahaleh', 'investigatorAffiliation': 'Weill Medical College of Cornell University'}}}}