Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-08 @ 11:18 AM
Study NCT ID:
NCT01980134
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2013-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The MORDIS Study Clinical Investigational Plan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D011127', 'term': 'Polyps'}], 'ancestors': [{'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples will be sent for pathological examination and potentially used for other research purposes.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2013-11-01', 'studyFirstSubmitQcDate': '2013-11-07', 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV > = 90% for diminutive colorectal lesions.', 'timeFrame': 'WavSTAT4 Optical Biopsy System gives real-time result. Outcomes are measured when comparing the physician and WavSTAT4 system result to pathology results, which usually take one to two weeks.', 'description': 'The WavSTAT4 Optical Biopsy System result will be compared to physician visual diagnosis as well as the subsequent pathological report.'}], 'secondaryOutcomes': [{'measure': 'Improved determination of post-polypectomy surveillance intervals', 'timeFrame': 'Outcome is measured when patients return for routine follow up. which is a long-term study as patients are not usually requested to return for another colonoscopy for many years.', 'description': 'To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps \\>5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenomatous colorectal lesions', 'colorectal polyps', 'polyps'], 'conditions': ['Adenoma']}, 'referencesModule': {'references': [{'pmid': '19910250', 'type': 'BACKGROUND', 'citation': 'Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate the use of WavSTAT4 system during colonoscopy in identifying diminutive colorectal lesions (e.g. hyperplastic polyps) that can be resected and discarded (or even left in-situ) without adverse clinical impact.', 'detailedDescription': 'To demonstrate the performance of the WavSTAT4 Optical Biopsy System when used at multiple centers.\n\nEndpoint targets are based on the ASGE PIVI recommendations on real-time endoscopic assessment of the histology of diminutive colorectal polyps.\n\n* Primary endpoint: To demonstrate potential of the WavSTAT4 Optical Biopsy System to predict adenomatous histology with a NPV \\> = 90% for diminutive colorectal lesions.\n* Secondary Endpoint: To show that use of the WavSTAT4 system used to determine histology of colorectal polyps ≤5 mm in size, when combined with the histo- pathologic assessment of polyps \\>5 mm in size, provides a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\~1200 patients ≥ 18 years of age at the time of enrollment showing presence of diminutive colorectal polyps.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and Female \\> 18 years\n* Standard indication for colonoscopy OR CRC screening OR follow-up examination after the diagnosis of one or more established polyps OR polypectomy (analysis of polyps other than the intended polypectomy)\n* Written informed consent\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Hereditary/genetic polyposis syndromes'}, 'identificationModule': {'nctId': 'NCT01980134', 'acronym': 'MORDIS', 'briefTitle': 'The MORDIS Study Clinical Investigational Plan', 'organization': {'class': 'OTHER', 'fullName': 'SpectraScience'}, 'officialTitle': 'Multicenter, Open, Prospective Study on Modified Resect and DIScard Strategy of Small Colonic Lesions Using WavSTAT4 Optical Biopsy System: The MORDIS Study Clinical Investigational Plan', 'orgStudyIdInfo': {'id': 'MORDIS Study 010044-002'}}, 'contactsLocationsModule': {'locations': [{'zip': 'Praha 4', 'city': 'Prague', 'state': 'Czech Republic', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'MUDR. M. Benes, MD', 'role': 'CONTACT', 'phone': '420 26136 4016'}, {'name': 'Prof. Julius Spicak, MD', 'role': 'CONTACT', 'phone': '420 26136 4016'}], 'facility': 'Klinika Hepatogastroenterologie Ikem', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2730', 'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Vilmann, MD', 'role': 'CONTACT', 'email': 'Peter.Vilmann@regionh.dk', 'phone': '4991318545053'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': '72076', 'city': 'Tübingen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Götz,, M.D.', 'role': 'CONTACT', 'email': 'martin.goetz@med.uni-tuebingen.de', 'phone': '+49 7071 29 82162'}, {'name': 'Nisar Peter Malek, M.D.', 'role': 'CONTACT', 'phone': '+49 7071 29 82162'}], 'facility': 'Universitäts Klinikum Tübingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '20141', 'city': 'Milan', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Christiano Crosta, MD', 'role': 'CONTACT', 'email': 'cristiano.crosta@ieo.it', 'phone': '+ 390257489067'}, {'name': 'Christiano Crosta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'European Institute of Oncology', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00168', 'city': 'Roma', 'state': 'Italy', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Guido Costamagna, MD', 'role': 'CONTACT', 'email': 'gcostamagna@rm.unicatt.it', 'phone': '+ 390630154083'}, {'name': 'Guido Costamagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico Universitario Gemeli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Ervin Toth, MD', 'role': 'CONTACT', 'email': 'ervin.toth@med.lu.se', 'phone': '46 40 33 1000/ 33 86 21'}], 'facility': 'SKANE University Hospital', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}], 'centralContacts': [{'name': 'Guido Costamagna, MD', 'role': 'CONTACT', 'email': 'gcostamagna@rm.unicatt.it', 'phone': '+390630154083'}], 'overallOfficials': [{'name': 'Guido Costamagna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Policlinico Gemeli, Roma, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SpectraScience', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Ospedaliera Universitaria Policlinico', 'class': 'OTHER'}, {'name': 'European Institute of Oncology', 'class': 'OTHER'}, {'name': "Institut des Maladies de l'Appareil digestif", 'class': 'UNKNOWN'}, {'name': 'European Georges Pompidou Hospital', 'class': 'OTHER'}, {'name': 'KU Leuven', 'class': 'OTHER'}, {'name': 'Innere Medizin I Interdisziplinäre Endoskopie Universitätsklinikum Tübingen', 'class': 'UNKNOWN'}, {'name': 'University of Erlangen-Nürnberg', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital at Herlev', 'class': 'OTHER'}, {'name': 'Skane University Hospital', 'class': 'OTHER'}, {'name': 'Institute for Clinical and Experimental Medicine', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}