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Primary Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

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ClinicalTrials.gov Identifier: NCT03985826
Recruitment Status : Not yet recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborator:
Research Unit for General Practice, Aarhus University
Information provided by (Responsible Party):
University of Aarhus

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.


Condition or disease Intervention/treatment
Precursor Cell Lymphoblastic Leukemia-Lymphoma Other: Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood

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.


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Study Type : Observational
Estimated Enrollment : 7700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Primary Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia: A Population-Based Cohort Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : July 2021


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.



Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. The monthly contact rate to general practice for ALL survivors [ Time Frame: 1-20 years follow-up ]
    Analysing longitudinal health care data with analysis of both first and recurrent events


Other Outcome Measures:
  1. The total annual contact rate for primary and 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



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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes 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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03985826


Contacts
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Contact: Karen S Jensen, MD 0045 61718432 kascje@rm.dk

Sponsors and Collaborators
University of Aarhus
Research Unit for General Practice, Aarhus University
Investigators
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Study Director: Peter Vedsted, Professor Research Unit for General Practice, Institute for Public Health

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT03985826     History of Changes
Other Study ID Numbers: ID277
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases