Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
As the NOPHO database probably is one of the most complete databases globally, it is an advantage to perform this study as a NOPHO study.
Results 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.
The 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.
The timing of the project is an increased focus on the clinical relevance of routine clinical follow-up of patients treated for cancer.
Study Design
Outcome Measures
Primary Outcome Measures
- Detection mode [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.]
The proportion of relapses diagnosed at a routine visit vs. relapses diagnosed at an extra scheduled visit.
Secondary Outcome Measures
- Survival [Time-to-Event measures (up to 23 years from date of relapse until censoring)]
Survival, by detection mode (routine or extra visit)
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosed with pre-B or T-cell ALL in the Nordic countries (Denmark, Sweden, Norway, Finland or Iceland)
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included in the NOPHO ALL-92, ALL-2000 or ALL-2008 trials
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treated in a Paediatric Department
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developing a relapse/SMN after cessation of maintenance therapy before 31st of December 2016
Exclusion Criteria:
- hematopoietic stem cell transplantation in first complete remission
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital | Aarhus N | Denmark | 8200 | |
| 2 | Department of Paediatrics and Adolescent Medicine, Turku University Hospital | Turku | Finland | 20521 | |
| 3 | The National University Hospital of Iceland | Reykjavík | Iceland | 101 | |
| 4 | Department of Childhood Oncology, University Hospital Tromsø | Tromsø | Norway | 9038 | |
| 5 | Department of Paediatric Oncology, Karolinska University Hospital | Stockholm | Sweden | 171 76 |
Sponsors and Collaborators
- University of Aarhus
Investigators
- Study Director: Henrik Schrøder, Professor, Aarhus University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALL-Relapse