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Childhood Acute Lymphoblastic Leukaemia: Follow-Up

Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03545659
Enrollment
277
Registered
2018-06-04
Start date
2018-09-04
Completion date
2021-01-20
Last updated
2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence

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.

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.

Interventions

OTHERMode of relapse/SMN detection

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.

Sponsors

University of Aarhus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Detection modeInvestigators 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

MeasureTime frameDescription
SurvivalTime-to-Event measures (up to 23 years from date of relapse until censoring)Survival, by detection mode (routine or extra visit)

Countries

Denmark, Finland, Iceland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026