Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-03-02 @ 8:38 PM
Study NCT ID:
NCT04097093
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Surival of GIST Patients ≥ 10 Years on Imatinib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'First, existing data on molecular characteristics of included patients will be collected from the treating centers. If more than 40% of the data is not available, archival tumor tissue from patients enrolled in the EORTC 62005-STBSG study will be collected and used to identify molecular characteristics of the tumor that may predict long-term response to imatinib. Archival tumor tissues will be retrieved from the central lab of the study 62005-STBSG (UZ Leuven, Belgium) or from the sites (if applicable).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Lack of feasibility', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2019-08-07', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient characteristics', 'timeFrame': 'At time of registration', 'description': 'Age at time of randomization, gender, medical history and previous treatment(s)'}, {'measure': 'Tumour characteristics', 'timeFrame': 'At time of registration', 'description': 'Stage of the disease, tumor grade, tumor location and molecular features of primary tumor'}, {'measure': 'Duration of imatinib treatment', 'timeFrame': 'At time of registration', 'description': 'Time on imatinib treatment from start untill definitive discontinuation of imatinib treatment'}, {'measure': 'Health releated quality of life', 'timeFrame': 'At time of registration', 'description': 'QLQ-C30'}, {'measure': 'Overall survival', 'timeFrame': 'At time of registration', 'description': 'From time of randomization to the date of death, whatever the cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GIST']}, 'descriptionModule': {'briefSummary': 'This is a cross-sectional cohort study of metastatic GastroIntestinal Stromal Tumor (GIST) patients on imatinib for ≥ 10 years included in EORTC trial 62005-STBSG entitled "Phase 3 randomized, intergroup, international tiral assessing the clinical activity of STI-571 at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) expressing the KIT receptor tyrosine kinase (CD117) - NCT00685828". With this study, the aim is to identify patient characteristics, tumour characteristics, treatment factors and quality of life outcomes associated with prolonged treatment with imatinib and/or prolonged survival. This observational study will further help to put in place a questionnaire to evaluate patients quality of life with prolonged imatinib treatment, that will then be used in a prospective study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '28 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients enrolled in the 62005 trial - treated for more than 10 years with imatinib - will be enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in the EORTC 62005 trial: Adult patients with metastasized GIST\n* Patients who have been treated with imatinib for ten years or longer\n* For the identified patients who are still alive:\n\n 1. Able to read and answer questionnaires\n 2. Able to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT04097093', 'briefTitle': 'Long-term Surival of GIST Patients ≥ 10 Years on Imatinib', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Long-term Survival of Advanced/Metastatic GIST Patients Responding to Imatinib Treatment: an Observational Follow-up Study', 'orgStudyIdInfo': {'id': 'EORTC 1826-STBSG'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Study 62005-STBSG patients treated with imatinib > 10 years', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Study 62005-STBSG patients treated with imatinib > 10 years']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Neeltje Steeghs', 'role': 'STUDY_CHAIR', 'affiliation': 'NKI - Antoni van Leeuwenhoekziekenhuis'}, {'name': 'Axel Le Cesne', 'role': 'STUDY_CHAIR', 'affiliation': 'Gustave Roussy, Cancer Campus, Grand Paris'}, {'name': 'Ingrid Desar', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud University Medical Center Nijmegen'}, {'name': 'Olga Husson', 'role': 'STUDY_CHAIR', 'affiliation': 'Radboud University Medical Center Nijmegen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}