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Clinical Trials/NCT03985826
NCT03985826
Completed
Not Applicable

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

University of Aarhus1 site in 1 country7,348 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Sponsor
University of Aarhus
Enrollment
7348
Locations
1
Primary Endpoint
The yearly contact rate to general practice for ALL survivors and controls
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
November 30, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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