The ALL-STAR study is a protocol for a population-based observational cohort study of 475 childhood acute lymphoblastic leukaemia survivors in Denmark to assess the burden of late health conditions.
Cohort (n=475)
Yes
The ALL-STAR study protocol outlines a national cohort study to evaluate the comprehensive somatic and psychosocial late effects in childhood ALL survivors in Denmark.
INTRODUCTION: More than 90% of patients diagnosed with childhood acute lymphoblastic leukaemia (ALL) today will survive. However, half of the survivors are expected to experience therapy-related chronic or late occurring adverse effects, reducing quality of life. Insight into underlying risk trajectories is warranted. The aim of this study is to establish a Nordic, national childhood ALL survivor cohort, to be investigated for the total somatic and psychosocial treatment-related burden as well as associated risk factors, allowing subsequent linkage to nation-wide public health registers. METHODS AND ANALYSIS: This population-based observational cohort study includes clinical follow-up of a retrospective childhood ALL survivor cohort (n=475), treated according to a common Nordic ALL protocol during 2008-2018 in Denmark. The study includes matched controls. Primary endpoints are the cumulative incidence and cumulative burden of 197 health conditions, assessed through self-report and proxy-report questionnaires, medical chart validation, and clinical examinations. Secondary endpoints include organ-specific outcome, including cardiovascular and pulmonary function, physical performance, neuropathy, metabolic disturbances, hepatic and pancreatic function, bone health, oral and dental health, kidney function, puberty and fertility, fatigue, and psychosocial outcome. Therapy exposure, acute toxicities, and host genome variants are explored as risk factors. ETHICS AND DISSEMINATION: The study is approved by the Regional Ethics Committee for the Capital Region in Denmark (H-18035090/H-20006359) and by the Danish Data Protection Agency (VD-2018-519). Results will be published in peer-reviewed journals and are expected to guide interventions that will ameliorate the burden of therapy without compromising the chance of cure.
Andrés‐Jensen et al. (Mon,) conducted a cohort in Childhood acute lymphoblastic leukaemia (ALL) (n=475). Childhood ALL treatment vs. Matched controls was evaluated on Cumulative incidence and cumulative burden of 197 health conditions. The ALL-STAR study is a protocol for a population-based observational cohort study of 475 childhood acute lymphoblastic leukaemia survivors in Denmark to assess the burden of late health conditions.