Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-03 @ 7:17 PM
Study NCT ID:
NCT03545659
Status:
COMPLETED
Last Update Posted:
2021-09-01
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 277}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-01', 'lastUpdatePostDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection mode', 'timeFrame': 'Investigators will review medical charts up to three months before the diagnosis of a relapse. Relapses will be categorized to be diagnosed by either a routine visit or an extra scheduled visit.', 'description': 'The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Time-to-Event measures (up to 23 years from date of relapse until censoring)', 'description': 'Survival, by detection mode (routine or extra visit)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Precursor Cell Lymphoblastic Leukemia-Lymphoma', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Over the past decades, advances in treatment have led to an increasing number of children who survive cancer, resulting in a growing population of childhood cancer survivors. After end of cancer treatment on common protocols survivors are enrolled in non-harmonized follow-up programs with frequent visits and blood samples. However, the evidence for the value of these follow-up programs with respect to the effect on detecting relapse and the effects on overall survival is scarce.\n\nThe aim of the study is to give a comprehensive description of the detection mode of relapsed acute lymphoblastic leukaemia (ALL), including symptoms and blood test results. Further, we aim to evaluate if the mode of detection affects survival.', 'detailedDescription': "Investigators have identified a cohort of children with B-precursor ALL and T-ALL enrolled in the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-92, ALL-2000 and ALL-2008 trials and experienced a relapse or an SMN as the first event after cessation of maintenance therapy (368 patients). From medical charts and blood test results it will be decided whether the relapse/SMN was diagnosed at a routine visit (including routine blood tests) or if the relapse was diagnosed because of symptoms at a non-scheduled visit or blood test.\n\nAs the NOPHO database probably is one of the most complete databases globally, it is an advantage to perform this study as a NOPHO study.\n\nResults of this population based relapse study will provide an evidence-based background for planning optimal and relevant follow-up programs for children after therapy of ALL treated according to contemporary Nordic ALL protocols.\n\nThe study is important and relevant in the light of today's high ALL cure rates and a need for optimal follow-up programs after cessation of ALL treatment and possible prediction of relapse.\n\nThe timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland)\n* included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials\n* treated in a Paediatric Department\n* developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016\n\nExclusion Criteria:\n\n* hematopoietic stem cell transplantation in first complete remission'}, 'identificationModule': {'nctId': 'NCT03545659', 'briefTitle': 'Childhood Acute Lymphoblastic Leukaemia: Follow-Up', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study', 'orgStudyIdInfo': {'id': 'ALL-Relapse'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Mode of relapse/SMN detection', 'type': 'OTHER', 'description': 'Mode of relapse/SMN detection: whether the relapse/SMN was diagnosed because of symptoms of leukaemia or diagnosed at a routine visit in the outpatient clinic.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Department of Paediatrics and Adolescent Medicine, Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '101', 'city': 'Reykjavik', 'country': 'Iceland', 'facility': 'The National University Hospital of Iceland', 'geoPoint': {'lat': 64.13548, 'lon': -21.89541}}, {'zip': '9038', 'city': 'Tromsø', 'country': 'Norway', 'facility': 'Department of Childhood Oncology, University Hospital Tromsø', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Department of Paediatric Oncology, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Henrik Schrøder, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aarhus University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}