Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT02386618
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2013-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Treatment for Local Residual Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-04', 'studyFirstSubmitDate': '2013-09-19', 'studyFirstSubmitQcDate': '2015-03-11', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of endoscopic treatment od local residual neoplasia (absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination)', 'timeFrame': '6 months', 'description': 'Efficacious endoscopic treatment is defined as absence of neoplastic tissue in post-EMR scar proven by endoscopic and histologic examination in 6 months after endoscopic treatment od local residual neoplasia.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colorectal cancer', 'laterally spreading tumors', 'endoscopic mucosal resestion', 'local residual neoplasia'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'Endoscopic mucosal resection (EMR) is considered to be a gold standard of therapy of colorectal lateral spreading tumors (LST) without significant risk for lymphatic spread. According to the investigators previous study, local residual neoplasia (LRN) after conventional endoscopic mucosal resection (EMR)occurs in up to 21% of cases. Endoscopic therapy of LRN was not sufficient in 53 % and has not been standardized yet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 18 years\n* patients with local residual neoplasia in scar in three months after endoscopic mucosal resection for laterally spreading tumor (0-IIa \\> 10 mm)\n* signed informed consent\n\nExclusion Criteria:\n\n* incomplete endoscopic mucosal resection\n* previous therapy for local residual neoplasia\n* difficult or impossible localization of post-EMR scar'}, 'identificationModule': {'nctId': 'NCT02386618', 'briefTitle': 'Endoscopic Treatment for Local Residual Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Vitkovice Hospital'}, 'officialTitle': 'Endoscopic Treatment for Local Residual Neoplasia After Endoscopic Mucosal Resection of the Colorectal Lateral Spreading Tumors (LST)', 'orgStudyIdInfo': {'id': 'DDC VN 07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Local residual neoplasia', 'description': 'Patients with local residual neoplasia in 3 months after endoscopic resection of colorectal lateral spreading tumors diagnosed endoscopically and/or histologically', 'interventionNames': ['Procedure: Standardized endoscopic treatment of local residual neoplasia']}], 'interventions': [{'name': 'Standardized endoscopic treatment of local residual neoplasia', 'type': 'PROCEDURE', 'description': 'Endoscopic treatment will be performed according to the type of local residual neoplasia (LRN): A - endoscopically negative scar and neoplastic tissue found only in biopsy specimens - treatment by argon plasmacoagulation, B - endoscopically aparent LRN \\< 5 mm - forceps biopsy + argon plasmacoagulation, C - endoscopically evident LRN \\> 5 mm + lifting during submucosal injection - endoscopic mucosal resectio + argon plasmacoagulation, D - endoscopically evident LRN \\> 5 mm + non-lifting during submucosal injection - endoscopic submucosal disection (ESD) or surgical resection', 'armGroupLabels': ['Local residual neoplasia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '703 84', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Vitkovice Hospital', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}], 'overallOfficials': [{'name': 'Premysl Falt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vitkovice Hospital, Ostrava'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitkovice Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUDr. Premysl Falt', 'investigatorFullName': 'Premysl Falt, M.D., Ph.D.', 'investigatorAffiliation': 'Vitkovice Hospital'}}}}