Health Care Utilisation Among Survivors of Childhood Acute Lymphoblastic Leukaemia

NCT03985826 | Completed DMC

• 1 other identifier: ID277
• Study Type: observational
• Target: 7,348
• Locations: 1 country
• Sites: 1

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.

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

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

  1-20 years follow-up

Study Arms (2)

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

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.

Interventions

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

Childhood ALL survivors

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Children with Down syndrome

Sponsors & Collaborators

• University of Aarhus: lead
• Research Unit for General Practice, Aarhus University: collaborator

Study Sites (1)

Department of Public Health

Aarhus C, 8000, Denmark

Location

Related Publications (1)

• Jensen KS, Klug Albertsen B, Schroder H, Zalounina Falborg A, Schmiegelow K, Rosthoj S, Callesen MT, Vedsted P. Health care utilisation following childhood acute lymphoblastic leukaemia: a population-based matched cohort study. BMJ Open. 2021 Nov 22;11(11):e049847. doi: 10.1136/bmjopen-2021-049847.

  PMID: 34810184 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Peter Vedsted, Professor

  Research Unit for General Practice, Institute for Public Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 14, 2019
• Study Start: September 1, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: December 3, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)