Childhood CancerNCT04811794
Young Survivors at Kantonsspital Aarau, Switzerland
An observational study of Childhood Cancer and Late Effects, run by Kantonsspital Aarau at 1 site in Switzerland.
Trial summary
The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Cancer, Late Effects
- What is being tested?
- Physical examination, diagnostic tests, laboratory tests and Personal history
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Mar 2021to 15 Mar 2072
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population includes all children, adolescents and adults who have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau and who have completed their treatment and have entered follow-up care.
Who may be able to join
- Group A:
- Children and adolescents who:
- have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau,
- have been diagnosed at age 0-18 years,
- are still in regular follow-up care at the Kantonsspital Aarau,
- have finished cancer treatment and entered follow-up care, and
Show all 11Show fewer
- signed informed consent
- Group B:
- Adolescents and adults who:
- fulfill the same inclusion criteria as Group A
- are not in regular follow-up care anymore
Who cannot join
- Childhood Cancer Survivors who:
- are in a palliative situation or
- have not given consent for further use of medical data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
Aarau
Katrin Scheinemann, MD, +41628384909, katrin.scheinemann@ksa.ch
Katrin Scheinemann, MD
About this study
Official title: Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer
The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.
Read the detailed description
Background:
Around 250-300 children and adolescents below the age of 21 years are newly diagnosed with cancer in Switzerland every year. Research led to remarkable progress in survival in the last decades. The 10-year survival rate in Switzerland is currently 87%. Previous research showed that, depending on the treatment exposure, a high proportion of these survivors suffer from chronic medical conditions, so called late effects.
Many studies on late effects in former childhood cancer patients are based on retrospective data. However, this type of study design has unavoidable limitations, such as missing data, different coding and grading of severity of late effects, and the assessment at different time points. Therefore, we need prospectively collected data, including severity coding in a standardized way, to overcome these limitations.
Objectives:
The overarching aim of "Young Survivors at Kantonsspital Aarau, Switzerland" is to assess late effects in childhood cancer survivors prospectively and in a standardized way. These data will contribute to the increasing knowledge on long-term outcomes and late effects in the future. This new knowledge is important in order to be able to adapt and improve long-term follow-up care. In the longer term, survivors will benefit from this extensive and prospective data collection.
Methods:
"Young Survivors at Kantonsspital Aarau" has a registry-like design. Data produced during regular follow-up visits are collected in a comprehensive database and in a standardized way. We collect all information generated prospectively from start of the study onwards and retrospectively until January 2016. From 2016 onward, all medical records are kept electronically. We classify and grade the severity of late effects according to the modified National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03). The outcome variables correspond to results from risk-stratified organ examinations, which are performed according to the Children's Oncology Group guidelines v5.0. The exposure variables correspond to information from the patients' medical history, including detailed information on cancer diagnosis and treatment. The data will be analyzed in an exposure- or organ system-driven approach. We start recruitment with patients diagnosed and treated at the Kantonsspital Aarau. The design of the study allows the inclusion of other clinics in the future.
Research and significance:
Research on late effects of former childhood cancer patients often relies on retrospective data collection, which is associated with unpreventable limitations. "Young Survivors at Kantonsspital Aarau" overcomes these limitations and additionally grades the severity of late effects in a standardized way. This allows us to analyze changes in severity of late effects over time, within and between survivors. This information will increase our knowledge on late effects and contribute to long-term follow-up care.
- Conditions
- Childhood Cancer, Late Effects
- Being tested
- Physical examination, diagnostic tests, laboratory tests, Personal history
- Keywords
- Childhood Cancer, Survivor, Late Effects, CTCAE
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examination, diagnostic tests, laboratory testsOther
Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.
Personal historyOther
Personal history on diagnosis, treatment, and socioeconomic factors
| Study group | Role | What they receive |
|---|---|---|
| Group A (largest part of the cohort) | Children, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most) Receives: Other: Physical examination, diagnostic tests, laboratory tests; Other: Personal history | |
| Group B (very small part of the cohort) | Children, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most) Receives: Other: Physical examination, diagnostic tests, laboratory tests; Other: Personal history |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test results to assess organ-specific late effects (example of cardiac health)
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects
Measured: at recruitment or 2016 onwards, whichever comes first
Secondary outcomes (5)
Test results to assess organ-specific late effects (example of cardiac health)
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction etc. when at risk for cardiac late effects
Measured: annually from recruitment or 2016 onwards, whichever comes first
Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)
Measured: annually from recruitment or 2016 onwards, whichever comes first
Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects
Measured: annually from recruitment or 2016 onwards, whichever comes first
Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)
Measured: at recruitment or 2016 onwards, whichever comes first
Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )
Measured: at recruitment or 2016 onwards, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start15 Mar 2021
- Primary completion15 Mar 2071 (estimated)
- Study completion15 Mar 2072 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Scheinemann, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811794
- Sponsor's protocol ID
- AO_2020-00012
- Status last verified
- Aug 2022
- First submitted
- 19 Mar 2021
- Last updated
- 17 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Otth M, Drozdov D, Hugli C, Scheinemann K. Young Survivors at KSA: registry for standardised assessment of long-term and late-onset health events in survivors of childhood and adolescent cancer-a study protocol. BMJ Open. 2021 Dec 3;11(12):e053749. doi: 10.1136/bmjopen-2021-053749.
PubMed 34862296
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer
- ClinicalTrials.gov ID
- NCT04811794
- Acronym / sponsor ID
- AO_2020-00012
- Conditions
- Childhood Cancer, Late Effects
- Keywords
- Childhood Cancer, Survivor, Late Effects, CTCAE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 15 Mar 2071 (estimated)
- Study completion
- 15 Mar 2072 (estimated)
- First posted
- 23 Mar 2021 (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 Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.
Detailed description
Background:
Around 250-300 children and adolescents below the age of 21 years are newly diagnosed with cancer in Switzerland every year. Research led to remarkable progress in survival in the last decades. The 10-year survival rate in Switzerland is currently 87%. Previous research showed that, depending on the treatment exposure, a high proportion of these survivors suffer from chronic medical conditions, so called late effects.
Many studies on late effects in former childhood cancer patients are based on retrospective data. However, this type of study design has unavoidable limitations, such as missing data, different coding and grading of severity of late effects, and the assessment at different time points. Therefore, we need prospectively collected data, including severity coding in a standardized way, to overcome these limitations.
Objectives:
The overarching aim of "Young Survivors at Kantonsspital Aarau, Switzerland" is to assess late effects in childhood cancer survivors prospectively and in a standardized way. These data will contribute to the increasing knowledge on long-term outcomes and late effects in the future. This new knowledge is important in order to be able to adapt and improve long-term follow-up care. In the longer term, survivors will benefit from this extensive and prospective data collection.
Methods:
"Young Survivors at Kantonsspital Aarau" has a registry-like design. Data produced during regular follow-up visits are collected in a comprehensive database and in a standardized way. We collect all information generated prospectively from start of the study onwards and retrospectively until January 2016. From 2016 onward, all medical records are kept electronically. We classify and grade the severity of late effects according to the modified National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03). The outcome variables correspond to results from risk-stratified organ examinations, which are performed according to the Children's Oncology Group guidelines v5.0. The exposure variables correspond to information from the patients' medical history, including detailed information on cancer diagnosis and treatment. The data will be analyzed in an exposure- or organ system-driven approach. We start recruitment with patients diagnosed and treated at the Kantonsspital Aarau. The design of the study allows the inclusion of other clinics in the future.
Research and significance:
Research on late effects of former childhood cancer patients often relies on retrospective data collection, which is associated with unpreventable limitations. "Young Survivors at Kantonsspital Aarau" overcomes these limitations and additionally grades the severity of late effects in a standardized way. This allows us to analyze changes in severity of late effects over time, within and between survivors. This information will increase our knowledge on late effects and contribute to long-term follow-up care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 50 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (largest part of the cohort) | – | Other: Physical examination, diagnostic tests, laboratory tests, Other: Personal historyChildren, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most) |
| Group B (very small part of the cohort) | – | Other: Physical examination, diagnostic tests, laboratory tests, Other: Personal historyChildren, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population includes all children, adolescents and adults who have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau and who have completed their treatment and have entered follow-up care.
Key inclusion criteria (11 listed)
- have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau,
- have been diagnosed at age 0-18 years,
- are still in regular follow-up care at the Kantonsspital Aarau,
- have finished cancer treatment and entered follow-up care, and
- signed informed consent
Key exclusion criteria (3 listed)
- are in a palliative situation or
- have not given consent for further use of medical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical examination, diagnostic tests, laboratory testsPhysical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system. | Other | Group A (largest part of the cohort), Group B (very small part of the cohort) |
| Personal historyPersonal history on diagnosis, treatment, and socioeconomic factors | Other | Group A (largest part of the cohort), Group B (very small part of the cohort) |
Primary outcome
Test results to assess organ-specific late effects (example of cardiac health)
Time frame: at recruitment or 2016 onwards, whichever comes first
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects
5 secondary outcomes
Test results to assess organ-specific late effects (example of cardiac health)
Time frame: annually from recruitment or 2016 onwards, whichever comes first
Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)
Time frame: annually from recruitment or 2016 onwards, whichever comes first
Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects
Time frame: annually from recruitment or 2016 onwards, whichever comes first
Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)
Time frame: at recruitment or 2016 onwards, whichever comes first
Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )
Time frame: at recruitment or 2016 onwards, whichever comes first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
- Derived from this study: PubMed 34862296Otth M, Drozdov D, Hugli C, Scheinemann K. Young Survivors at KSA: registry for standardised assessment of long-term and late-onset health events in survivors of childhood and adolescent cancer-a study protocol. BMJ Open. 2021 Dec 3;11(12):e053749. doi: 10.1136/bmjopen-2021-053749.
- 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.
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 Childhood Cancer and Late Effects, run by Kantonsspital Aarau at 1 site in Switzerland.
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 11 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 17 Aug 2022. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrin Scheinemann, MD (+41628384909, katrin.scheinemann@ksa.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test results to assess organ-specific late effects (example of cardiac health) (time frame: at recruitment or 2016 onwards, whichever comes first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04811794, which also lists 1 linked publication.
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 17 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.