COVID-19 and Childhood Cancer

COVID-19 and Childhood Cancer - Diagnostic Delay, Survival, and COVID-19 Susceptibility

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Childhood Cancer; Childhood Leukemia, Acute Lymphoblastic

• Study Type: Observational
• Enrollment (Estimated): 100000

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17177
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-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

Description

Inclusion Criteria for studying severe COVID-19 among childhood cancer survivors:

• 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.

Inclusion Criteria for studying childhood cancer incidence and survival and number of contacts with healthcare before the childhood cancer diagnosis:

- All children (age 0-19) diagnosed with cancer from 2015 in Sweden and Denmark

Exclusion Criteria:

• No exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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-)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: The Swedish Research Council; The Swedish Childhood Cancer Fund
• Investigators: Principal Investigator: Giorgio Tettamanti, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: June 28, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Childhood Cancer; Cohort Study; Childhood Cancer Incidence; Childhood Cancer Survival; Childhood Leukemia, Acute Lymphoblastic; Register Study
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Hematologic Diseases; Leukemia, Lymphoid; Leukemia; COVID-19; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 2022-06312

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