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

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Andrés-Jensen, L, Skipper, MT, Mielke Christensen, K, Hedegaard Johnsen, P, Aagaard Myhr, K, Kaj Fridh, M, Grell, K, Pedersen, AML, Leisgaard Mørck Rubak, S, Ballegaard, M, Hørlyck, A, Beck Jensen, R, Lambine, T-L, Gjerum Nielsen, K, Tuckuviene, R, Skov Wehner, P, Klug Albertsen, B, Schmiegelow, K & Frandsen, TL 2021, 'National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia: the ALL-STAR study protocol', BMJ Open, bind 11, nr. 2, e045543, s. 1-12. https://doi.org/10.1136/bmjopen-2020-045543

APA

Andrés-Jensen, L., Skipper, M. T., Mielke Christensen, K., Hedegaard Johnsen, P., Aagaard Myhr, K., Kaj Fridh, M., Grell, K., Pedersen, A. M. L., Leisgaard Mørck Rubak, S., Ballegaard, M., Hørlyck, A., Beck Jensen, R., Lambine, T-L., Gjerum Nielsen, K., Tuckuviene, R., Skov Wehner, P., Klug Albertsen, B., Schmiegelow, K., & Frandsen, T. L. (2021). National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia: the ALL-STAR study protocol. BMJ Open, 11(2), 1-12. [e045543]. https://doi.org/10.1136/bmjopen-2020-045543

CBE

MLA

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Author

Andrés-Jensen, Liv ; Skipper, Mette Tiedemann ; Mielke Christensen, Kristian ; Hedegaard Johnsen, Pia ; Aagaard Myhr, Katrine ; Kaj Fridh, Martin ; Grell, Kathrine ; Pedersen, A M L ; Leisgaard Mørck Rubak, Sune ; Ballegaard, Martin ; Hørlyck, Arne ; Beck Jensen, Rikke ; Lambine, Trine-Lise ; Gjerum Nielsen, Kim ; Tuckuviene, Ruta ; Skov Wehner, Peder ; Klug Albertsen, Birgitte ; Schmiegelow, Kjeld ; Frandsen, Thomas Leth. / National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia : the ALL-STAR study protocol. I: BMJ Open. 2021 ; Bind 11, Nr. 2. s. 1-12.

Bibtex

@article{5c742c85d0334ea898fdb48eff716cfd,
title = "National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia: the ALL-STAR study protocol",
abstract = "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.",
keywords = "adverse events, chemotherapy, leukaemia, paediatrics",
author = "Liv Andr{\'e}s-Jensen and Skipper, {Mette Tiedemann} and {Mielke Christensen}, Kristian and {Hedegaard Johnsen}, Pia and {Aagaard Myhr}, Katrine and {Kaj Fridh}, Martin and Kathrine Grell and Pedersen, {A M L} and {Leisgaard M{\o}rck Rubak}, Sune and Martin Ballegaard and Arne H{\o}rlyck and {Beck Jensen}, Rikke and Trine-Lise Lambine and {Gjerum Nielsen}, Kim and Ruta Tuckuviene and {Skov Wehner}, Peder and {Klug Albertsen}, Birgitte and Kjeld Schmiegelow and Frandsen, {Thomas Leth}",
note = "{\textcopyright} Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",
year = "2021",
month = feb,
day = "9",
doi = "10.1136/bmjopen-2020-045543",
language = "English",
volume = "11",
pages = "1--12",
journal = "BMJ Paediatrics Open ",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "2",

}

RIS

TY - JOUR

T1 - National, clinical cohort study of late effects among survivors of acute lymphoblastic leukaemia

T2 - the ALL-STAR study protocol

AU - Andrés-Jensen, Liv

AU - Skipper, Mette Tiedemann

AU - Mielke Christensen, Kristian

AU - Hedegaard Johnsen, Pia

AU - Aagaard Myhr, Katrine

AU - Kaj Fridh, Martin

AU - Grell, Kathrine

AU - Pedersen, A M L

AU - Leisgaard Mørck Rubak, Sune

AU - Ballegaard, Martin

AU - Hørlyck, Arne

AU - Beck Jensen, Rikke

AU - Lambine, Trine-Lise

AU - Gjerum Nielsen, Kim

AU - Tuckuviene, Ruta

AU - Skov Wehner, Peder

AU - Klug Albertsen, Birgitte

AU - Schmiegelow, Kjeld

AU - Frandsen, Thomas Leth

N1 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

PY - 2021/2/9

Y1 - 2021/2/9

N2 - 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.

AB - 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.

KW - adverse events

KW - chemotherapy

KW - leukaemia

KW - paediatrics

UR - http://www.scopus.com/inward/record.url?scp=85100985039&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2020-045543

DO - 10.1136/bmjopen-2020-045543

M3 - Journal article

C2 - 33563628

VL - 11

SP - 1

EP - 12

JO - BMJ Paediatrics Open

JF - BMJ Paediatrics Open

SN - 2044-6055

IS - 2

M1 - e045543

ER -

ID: 62240177