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NCT Number: NCT03985826

Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

Improved understanding of the long-time healthcare utilisation of childhood cancer survivors is relevant as it can be seen as a proxy for the population's morbidity.

The investigators will conduct a historic population-based matched cohort study using Danish nationwide registry data. Eligible children are children 1.0-17.9 years diagnosed with Acute lymphoblastic leukaemia (ALL) in Denmark from 1994 till 2016. The primary outcome is yearly contact rates to primary healthcare.

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Key information

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Public Health

Aarhus C, 8000, Denmark

About this study

Acute lymphoblastic leukaemia (ALL) is the most frequent single form of cancer in children accounting for 40-45 new cases every year in Denmark. Over the past decades, advances in treatment have led to an increasing number of children who survive cancer and more than 80% of children with ALL now become long-term survivors. This means a growing population of childhood ALL survivors. In survivors, the cancer itself and treatment late-effects can lead to ongoing health care use.

Register studies of long-term survivors of childhood cancer have shown an increased risk of hospitalisation compared to the general population. It is mentioned in many of the studies that contact rates could be underestimated when looking at hospital contacts only.

The literature about non-hospital-based contacts with a doctor in childhood cancer survivors is scarce.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • B-precursor ALL and T-ALL enrolled in the NOPHO ALL-92, ALL-2000 and ALL-2008 trials.
  • Treated at one of the four Danish paediatric oncology departments
  • Age group 1.0-14.9 for the NOPHO ALL-92 and ALL-2000 trials. Age group 1.0-17.9 for the NOPHO ALL-2008 trial.
  • Completed maintenance therapy in the time period form 01.01.1997 till 31.12.2016

Exclusion criteria

  • Children with Down syndrome

Treatment and study plan

Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood

Other

The cohort of ALL survivors has all been diagnosed and treated for ALL in childhood

Primary outcomes

  1. The yearly contact rate to general practice for ALL survivors and controls

    Time frame: 1-20 years follow-up

    Analysing longitudinal health care data with analysis of both first and recurrent events

Other outcomes

  1. The yearly contact rate to secondary healthcare for ALL survivors and controls

    Time frame: 1-20 years follow-up

    Analysing longitudinal health care data with analysis of both first and recurrent events

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Research Unit for General Practice, Aarhus University

Registry information

Official study title

Health Care Utilisation Following Childhood Acute Lymphoblastic Leukaemia: A Matched Cohort Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 14, 2019
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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