Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT04759794
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2021-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Validation of an Immunocytochemistry Method Using MARS1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001651', 'term': 'Cholestasis, Extrahepatic'}], 'ancestors': [{'id': 'D002779', 'term': 'Cholestasis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The conventional staining method and new staining method will be performed in cytology specimens obtained from the same patient.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The usefulness of new staining method', 'timeFrame': '1 year', 'description': 'The sensitivity, specificity, positive predictive value, negative predictive value and accuracy of new staining method will be compared with th conventional Pap staining of brushing cytology specimens.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bile duct obstruction, extrahepatic', 'cytology', 'aminoacyl-tRNA synthetases'], 'conditions': ['Bile Duct Obstruction, Extrahepatic']}, 'descriptionModule': {'briefSummary': 'The sensitivity of brushing cytology used to distinguish the cause of biliary strictures is low and clinical usefulness is not secured. The aim of this study was to validate the clinical usefulness of a new differential staining method for cytology which is difficult to differentiate by the conventional staining method using biliary cancer-related protein expressed only in bile duct cancer.', 'detailedDescription': 'Hypothesis: The statistical significance of new staining method using aminoacyl-tRNA synthetases (ARSs) group in normal bile duct cells and the bile duct cancer cells collected by endoscopic retrograde pancreaticoduodenoscopy (ERCP) will be compared to prove the usefulness of the new staining method.\n\nClinical study design: The bile duct cytology will be obtained by brushing cytology using ERCP in patients with biliary stenosis. The expression of ARSs in the brushing cytology will be evaluated by a new staining method and compare with the results of the conventional cytology staining method including Papanicolaou staining. Immunofluorescence or immunocytochemistry staining will be performed to differentiate the presence of the tumor. The sensitivity and specificity of the new staining method will be compared with the conventional staining method and its usefulness be confirmed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with biliary cancer confirmed by imaging (CT, MRI, positron emission tomography)\n* Patients with bile duct cancer diagnosed using brushing cytology by endoscopic retrograde pancreaticoduodenoscopy\n* Patients who underwent surgical treatment with biliary cancer\n* Patients with bile duct stenosis\n\nExclusion Criteria:\n\n* Minors under the age of 19, vulnerable subjects such as illiteracy\n* Necrotic specimens\n* Samples with non-diagnostic cytology results and insufficient cells for further evaluation\n* Samples classified as neoplastic (benign or other)\n* Patient with cholangitis in the bile duct'}, 'identificationModule': {'nctId': 'NCT04759794', 'acronym': 'MARS1', 'briefTitle': 'Clinical Validation of an Immunocytochemistry Method Using MARS1', 'organization': {'class': 'OTHER', 'fullName': 'Gangnam Severance Hospital'}, 'officialTitle': 'Clinical Validation of an Immunocytochemistry Method Using Antibody of Methionyl-tRNA Synthetase (MARS1) in the Bile Duct Cancer Cell; Multicenter Study', 'orgStudyIdInfo': {'id': '3-2020-0514'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bile duct stenosis', 'description': 'This arm includes patients with bile duct stenosis. Endobiliary brushing cytology specimens will be obtained with endoscopic retrograde cholangiopancreatography (ERCP) of patients with bile duct stenosis. Cytology staining will be performed in the cytology specimens.', 'interventionNames': ['Diagnostic Test: Cytology staining']}], 'interventions': [{'name': 'Cytology staining', 'type': 'DIAGNOSTIC_TEST', 'description': 'Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography\n\n1. conventional cytology staining method\n2. new cytology staining method using the antibody of aminoacyl-tRNA synthetases', 'armGroupLabels': ['Bile duct stenosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13496', 'city': 'Seongnam', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'CHA Bundang Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '06229', 'city': 'Seoul', 'state': 'Gangnam-gu', 'country': 'South Korea', 'facility': 'Gangnam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '22332', 'city': 'Incheon', 'state': 'Jung-gu', 'country': 'South Korea', 'facility': 'In Ha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '31151', 'city': 'Cheonan', 'state': 'Namdong-gu', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital, Cheonan', 'geoPoint': {'lat': 36.8065, 'lon': 127.1522}}, {'zip': '49241', 'city': 'Busan', 'state': 'Seo-gu', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}], 'overallOfficials': [{'name': 'Sung Ill Jang, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institutional Review Board, Gangnam Severance Hospital Yonsei University College of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'We plan to share the following individual participant data with other researchers during the study period.', 'accessCriteria': '* Primary investigator\n* Sub primary investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gangnam Severance Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Sung III Jang', 'investigatorAffiliation': 'Gangnam Severance Hospital'}}}}