Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2026-03-16 @ 3:48 PM
Study NCT ID:
NCT03075969
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2017-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Taiwan', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2017-03-06', 'studyFirstSubmitQcDate': '2017-03-06', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary objective of the study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjunction with the QLQ-C30 for patients diagnosed with CML.', 'timeFrame': '18 months from enrollment'}], 'secondaryOutcomes': [{'measure': 'The secondary objective is to investigate longitudinal relationship between satisfaction with information provision (outcome measure: EORTC INFO-25) and QoL outcomes (outcome measures: EORTC QLQ-C30 and QLQ-CML24).', 'timeFrame': '18 months from enrollment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic myeloid leukemia; quality of life'], 'conditions': ['Chronic Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to test the scale structure, reliability, validity and responsiveness to change of the QLQ-CML24 in conjuction with the QLQ-C30 for patients diagnosed with CML, and to investigate longitudinal relationship between satisfaction with information provision and QoL outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study sample will be composed of four different groups of patients in order to achieve the purposes of this field-testing.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years of age.\n* Patient with confirmed diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive chronic myeloid leukemia (CML).\n* Written informed consent.\n* Patients enrolled in investigational drug-trials or other type of clinical trials are also eligible.\n\nExclusion Criteria:\n\n* Patients with a psychiatric condition or major cognitive impairment (as evaluated by their treating physician) that would hinder completion of self-reported health-related QoL questionnaires.\n* Patients who are unable to speak and read the language of the questionnaire.'}, 'identificationModule': {'nctId': 'NCT03075969', 'briefTitle': 'Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Gruppo Italiano Malattie EMatologiche dell'Adulto"}, 'officialTitle': 'An International Field Study for the Reliability and Validity of the Phase IV EORTC Quality of Life Module for Patients With Chronic Myeloid Leukemia (EORTC QLQ-CML24)', 'orgStudyIdInfo': {'id': 'QoL-CML 0916'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Emory', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute of Emory University', 'geoPoint': {'lat': 33.78899, 'lon': -84.32076}}, {'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Innsbruck Medical University', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'city': 'Paranã', 'country': 'Brazil', 'facility': 'Complexo Hospital de Clinicas da Universidade Federal do Parana', 'geoPoint': {'lat': -12.61528, 'lon': -47.88306}}, {'city': 'Guangdong', 'country': 'China', 'facility': 'Guangdong Medical University', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}, {'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Universität Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'city': 'Baghdad', 'country': 'Iraq', 'facility': 'Baghdad Teaching Hospital', 'geoPoint': {'lat': 33.34058, 'lon': 44.40088}}, {'city': 'Ancona', 'country': 'Italy', 'facility': 'Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. 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