National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia: The ALL-STAR study protocol

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  • Liv Andrés-Jensen, Københavns Universitet
  • ,
  • Mette Tiedemann Skipper
  • Kristian Mielke Christensen, Københavns Universitet
  • ,
  • Pia Hedegaard Johnsen
  • ,
  • Katrine Aagaard Myhr, Københavns Universitet
  • ,
  • Martin Kaj Fridh, Københavns Universitet
  • ,
  • Kathrine Grell, Københavns Universitet
  • ,
  • A. M.L. Pedersen, Københavns Universitet
  • ,
  • Sune Leisgaard Mørck Rubak
  • Martin Ballegaard, Sjællands Universitetshospital, Københavns Universitet
  • ,
  • Arne Hørlyck
  • Rikke Beck Jensen, Københavns Universitet
  • ,
  • Trine Lise Lambine, Københavns Universitet
  • ,
  • Kim Gjerum Nielsen, Københavns Universitet
  • ,
  • Ruta Tuckuviene, Aalborg Universitet
  • ,
  • Peder Skov Wehner, Syddansk Universitet
  • ,
  • Birgitte Klug Albertsen
  • Kjeld Schmiegelow, Københavns Universitet
  • ,
  • Thomas Leth Frandsen, Københavns Universitet

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.

TidsskriftBMJ Open
Antal sider12
StatusUdgivet - feb. 2021

Bibliografisk note

Funding Information:
Funding This study has received funding from the Danish Children’s Cancer Foundation (2017–2082; 2019–5966), The Danish Cancer Society (R192-A11.590), Cancer Survivorship and General Late effects (CASTLE, F-2 23 724–03), The Danish Cancer Research Foundation (FID20823), NordForsk (ID 91 172), Engineer Otto Christensen’s Foundation (101459), University of Aarhus (grant number not applicable), Holm’s Memorial Foundation (20 006–1975), AP Moeller Foundation (18-L-0225 L-0225), Farmer of Oelufgaard Memorial Foundation (grant number not applicable) and Skagen Teddy Bear Museum (grant number not applicable). The funding bodies have not had a role in the design, manuscript writing or in the decision to submit the manuscript for publication, nor will they have in the collection of data, analysis or interpretation.

Publisher Copyright:
© The Author(s), 2021.

Copyright 2021 Elsevier B.V., All rights reserved.

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