COVID-19NCT06482281
COVID-19 and Childhood Cancer
An observational study of COVID-19 and Childhood Cancer, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Childhood Cancer, Childhood Leukemia, Acute Lymphoblastic
- How many people
- 100,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
None listed.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Keywords
- Childhood Cancer, Childhood Cancer Incidence, Childhood Cancer Survival, Childhood Leukemia, Acute Lymphoblastic, Cohort Study, Register Study
- Medical subject headings
- COVID-19, Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 3 years
Childhood cancer survival
Overall survival after a childhood cancer diagnosis
Measured: 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
Measured: 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
Measured: From 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, The Swedish Childhood Cancer Fund
- Responsible party
- Principal investigator, Giorgio Tettamanti, Karolinska Institutet
- Investigators
- Giorgio Tettamanti, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482281
- Sponsor's protocol ID
- 2022-06312
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and Childhood Cancer - Diagnostic Delay, Survival, and COVID-19 Susceptibility
- ClinicalTrials.gov ID
- NCT06482281
- Acronym / sponsor ID
- 2022-06312
- Keywords
- Childhood Cancer, Childhood Cancer Incidence, Childhood Cancer Survival, Childhood Leukemia, Acute Lymphoblastic, Cohort Study, Register Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- The Swedish Research Council, The Swedish Childhood Cancer Fund
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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-) |
Who may qualify
- Ages
- 0 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Severe COVID-19
Time frame: Up to 3 years
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
Childhood cancer survival
Time frame: After three and twelve months after the cancer diagnosis and three years after cancer diagnosis
Overall survival after a childhood cancer diagnosis
Number of contacts before childhood cancer diagnosis
Time frame: One year before cancer diagnosis
Number of healthcare contacts (including primary care) the year before the cancer diagnosis
Childhood cancer incidence
Time frame: From 2015
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giorgio Tettamanti, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Childhood Cancer, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe COVID-19 (time frame: Up to 3 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.