NCT06482281

Brief Summary

The investigators will first examine the impact of the COVID-19 pandemic on childhood cancer patients in Sweden and Denmark, both regarding susceptibility to severe COVID-19 among long-term childhood cancer survivors, and, for those diagnosed with childhood cancer during the pandemic, whether the path through primary care to cancer diagnosis as well as short-term survival has changed. Second, the investigators will study childhood cancer incidence before, during and after the pandemic with the particular aim to test the hypothesis regarding an infectious disease etiology for acute lymphoblastic leukemia.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

June 28, 2024

Last Update Submit

July 2, 2024

Conditions

Keywords

Childhood CancerChildhood Cancer IncidenceChildhood Cancer SurvivalChildhood Leukemia, Acute LymphoblasticCohort StudyRegister Study

Outcome Measures

Primary Outcomes (4)

  • Severe COVID-19

    Defined as: * death with COVID-19 listed as a cause of death * hospitalization, or admission to intensive care unit, because of COVID-19 (main diagnosis) or respiratory problems (main diagnosis) AND COVID-19 as secondary diagnosis

    Up to 3 years

  • Childhood cancer survival

    Overall survival after a childhood cancer diagnosis

    After three and twelve months after the cancer diagnosis and three years after cancer diagnosis

  • Number of contacts before childhood cancer diagnosis

    Number of healthcare contacts (including primary care) the year before the cancer diagnosis

    One year before cancer diagnosis

  • Childhood cancer incidence

    Age standardized incidence rates for childhood cancer and cancer subtypes (particularly acute lymphoblastic leukemia) in Sweden and Denmark during and after the pandemic and compare it to the 5 years preceding the pandemic

    From 2015

Study Arms (4)

Childhood cancer survivors

Childhood cancer cases (0-19 years old) reported to the national cancer registers from 1971 in Sweden and Denmark, who were alive five years after the cancer diagnosis

Matched comparisons

Five general population comparisons were randomly selected and matched to the childhood cancer survivors by sex and year of birth

Siblings

All siblings of the childhood cancer survivors

Childhood cancer cases

Childhood cancer cases (0-19 years old) reported to the national cancer registers from 2015 in Sweden and Denmark. They will then further divided in three groups: before the pandemic (2015-2019), during the pandemic (2020-2022), and after the pandemic (2022-)

Eligibility Criteria

Age0 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* Childhood cancer cases (age 0-19) diagnosed from 1971 in Sweden and Denmark who were alive five years after diagnosis + their matched comparisons AND all siblings of the childhood cancer survivors * All children (age 0-19) diagnosed with cancer from 2015 in Sweden and Denmark

You may qualify if:

  • Childhood cancer cases (age 0-19) diagnosed from 1971 in Sweden and Denmark who were alive five years after diagnosis
  • Two different comparisons groups: five age- and sex-matched comparisons for each childhood cancer survivor as well as all siblings of the childhood cancer survivors.
  • All childhood cancer survivors, matched comparisons, and siblings of the survivors should be 20+ at the start of 2020.
  • \- All children (age 0-19) diagnosed with cancer from 2015 in Sweden and Denmark

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 17177, Sweden

Location

MeSH Terms

Conditions

COVID-19NeoplasmsPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Giorgio Tettamanti, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior research specialist, Docent

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 1, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations