Clinical trial NCT03545659: Childhood Acute Lymphoblastic Leukaemia: Follow-Up
Official title: Childhood Acute Lymphoblastic Leukaemia: The Effect of Follow-Up Programs for Detection of Relapse. A Nordic Population-Based Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Recurrence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 277
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be identified in the Nordic Society of Paediatric Haematology and Oncology ALL database.

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.

Eligibility criteria: 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

Primary outcomes:
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.
Secondary outcomes:
measure: Survival
timeFrame: Time-to-Event measures (up to 23 years from date of relapse until censoring)
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital
city: Turku
country: Finland
facility: Department of Paediatrics and Adolescent Medicine, Turku University Hospital
city: Reykjavík
country: Iceland
facility: The National University Hospital of Iceland
city: Tromsø
country: Norway
facility: Department of Childhood Oncology, University Hospital Tromsø
city: Stockholm
country: Sweden
facility: Department of Paediatric Oncology, Karolinska University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Henrik Schrøder, Professor
role: STUDY_DIRECTOR
References: