Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

December 1, 2020 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7348

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus C, Denmark, 8000
        • Department of Public health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology ALL database.

A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Childhood ALL survivors
The cohort of childhood ALL survivors will be identified in the Danish part of the Nordic Society of Paediatric Haematology and Oncology (NOPHO) ALL-Register .
Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood
The cohort of ALL survivors has all been diagnosed and treated for ALL in childhood
Comparison cohort
A reference cohort (comparison cohort) of individuals will be sampled randomly from the source population matched by age and sex and without a history of childhood cancer in the calendar year where the case was diagnosed (density sampling). For each childhood ALL-patient we will choose ten comparison subjects.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-20 years follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-20 years follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Research Unit for General Practice, Aarhus University

Investigators

  • Study Director: Peter Vedsted, Professor, Research Unit for General Practice, Institute for Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

June 11, 2019

First Submitted That Met QC Criteria

June 13, 2019

First Posted (Actual)

June 14, 2019

Study Record Updates

Last Update Posted (Actual)

December 3, 2020

Last Update Submitted That Met QC Criteria

December 1, 2020

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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