Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT04731220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-01-29
First Post:
2021-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Questionnaire Survey for Biliary Tract Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001661', 'term': 'Biliary Tract Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-28', 'studyFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and percentage of cases and controls who complete each part of the study', 'timeFrame': '5 years', 'description': 'Information is obtained by a questionnaire, laboratory findings, image data, physiological parameter.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is:\n\n* To evaluate risk factors for cancers of the biliary tract by registering new patients and their counterparts in a multi-center program\n* Development of programs by creating a multi-center biliary tract cancer registration system'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population should be defined in advance, stating eligibility criteria.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Study population :\n\n * Newly diagnosis of biliary tract cancers - Pathological or Radiological or other clinical diagnosis of biliary tract cancers\n * Informed consent\n* Control :\n\n * with no previous cancer diagnosis\n * Informed consent\n\nExclusion Criteria:\n\n* Previous diagnosis of bile duct cancer with resection operation, endoscopic resection, chemotherapy or radiation therapy\n* Prior diagnosis of other cancer in 5 years or ongoing cancer treatment\n* Patients' refusal"}, 'identificationModule': {'nctId': 'NCT04731220', 'briefTitle': 'A Questionnaire Survey for Biliary Tract Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Chilgok Hospital'}, 'officialTitle': 'A Questionnaire Survey Study for Establishment of Surveillance and Prevention Through the Analysis of Epidemiologic Risk Factors in Patients With Biliary Tract Cancers', 'orgStudyIdInfo': {'id': 'KNUCH 2020-04-045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study group', 'description': 'Newly diagnosed as bile duct cancer'}, {'label': 'Control group', 'description': 'No history of cancer in previous 5 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'KS002', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Chilgok Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Chilgok Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Hospital', 'class': 'OTHER'}, {'name': 'Pusan National University Yangsan Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}