Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 5:04 PM
Study NCT ID:
NCT03602092
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Registry Data on GIST Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046152', 'term': 'Gastrointestinal Stromal Tumors'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'C-KIT'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2018-07-16', 'studyFirstSubmitQcDate': '2018-07-25', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To establish the database for GIST', 'timeFrame': 'From date of registration to 31 December 2025', 'description': 'By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Stromal Tumors']}, 'descriptionModule': {'briefSummary': 'This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.', 'detailedDescription': 'Research question and objectives:\n\nThis study is to collect and describe real-world data for Taiwanese GIST on:\n\n* Prevalence and demographic characteristics of Taiwanese GIST\n* Treatment pattern of GIST therapies\n* Bio-marker and/or gene expression characteristics of Taiwanese GIST\n* Treatment outcome of TKI therapies, including recurrence-free, progression-free and overall survival\n* Safety profile for TKI therapies\n\nStudy design: Retrospective and prospective observational cohort study Population: Taiwan GIST patients during 01 January 2010 to 31 December 2020 Data sources: Medical records and investigator-established data bank Study size: Data from up to 3,000 eligible subjects will be collected Data analysis: Descriptive statistics for longitudinally assess nationwide trends on current and evolving diagnostic, treatment, and outcome measures in the GIST population and estimate the prevalence of GIST in Taiwan.\n\nMilestones: Interim report before 31 December 2018 and final study report before 30 June 2026.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with Gastrointestinal Stromal Tumor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with Gastrointestinal Stromal Tumor\n2. ≥20 years old\n3. Histology-confirmed GIST between 01 January 2010 and 31 December 2020.\n4. Patient with prospective data collection: Willing to provide singed inform-consent as per local regulatory requirements.\n\nExclusion Criteria:\n\n1. Inability and unwillingness to give informed consent if required by site ethic committee.\n2. Patient that is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or with severe concomitant illnesses per investigator judgement'}, 'identificationModule': {'nctId': 'NCT03602092', 'briefTitle': 'Observational Registry Data on GIST Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Health Research Institutes, Taiwan'}, 'officialTitle': 'The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)', 'orgStudyIdInfo': {'id': 'T1218'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observation', 'type': 'OTHER', 'description': 'This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10048', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wei-lan Yu, College', 'role': 'CONTACT', 'email': 'wlyu@nhri.org.tw', 'phone': '+886-2-23123456', 'phoneExt': '67658'}, {'name': 'Hui-Jen Tsai', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yu wei-lan', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hui-Jen Tsai, M.D', 'role': 'CONTACT', 'email': 'hjtsai@nhri.org.tw', 'phone': '886-06-2083427', 'phoneExt': '65149'}, {'name': 'Wei-Lan Yu, MSN', 'role': 'CONTACT', 'email': 'wlyu@nhri.org.tw', 'phone': '886-2-3123456', 'phoneExt': '67658'}], 'overallOfficials': [{'name': 'Tsang-Wu Liu, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Taiwan Cooperation Organization Group,NHRI,Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, {'name': 'China Medical University Hospital', 'class': 'OTHER'}, {'name': 'Changhua Christian Hospital', 'class': 'OTHER'}, {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'Kaohsiung Medical University', 'class': 'OTHER'}, {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}