Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03985826
• Other study ID #: ID277
• Status: Completed
• Start date: September 1, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: June 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7348
• Est. completion date: November 30, 2019
• Est. primary completion date: November 30, 2019
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Public Health	Aarhus C

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Research Unit for General Practice, Aarhus University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The yearly contact rate to secondary healthcare for ALL survivors and controls	Analysing longitudinal health care data with analysis of both first and recurrent events	1-20 years follow-up
Primary	The yearly contact rate to general practice for ALL survivors and controls	Analysing longitudinal health care data with analysis of both first and recurrent events	1-20 years follow-up