Recurrence Clinical Trial
Official title:
Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study
Verified date | June 2020 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. The 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.
Status | Completed |
Enrollment | 277 |
Est. completion date | January 20, 2021 |
Est. primary completion date | December 30, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 1 Year to 18 Years |
Eligibility | Inclusion Criteria: - diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland) - included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials - treated in a Paediatric Department - developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016 Exclusion Criteria: - hematopoietic stem cell transplantation in first complete remission |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital | Aarhus N | |
Finland | Department of Paediatrics and Adolescent Medicine, Turku University Hospital | Turku | |
Iceland | The National University Hospital of Iceland | Reykjavík | |
Norway | Department of Childhood Oncology, University Hospital Tromsø | Tromsø | |
Sweden | Department of Paediatric Oncology, Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark, Finland, Iceland, Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Detection mode | The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit. | 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. | |
Secondary | Survival | Survival, by detection mode (routine or extra visit) | Time-to-Event measures (up to 23 years from date of relapse until censoring) |
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