Late EffectSCCSS-FUNCT04732273
The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)
An observational study of Late Effect and Childhood Cancer, run by University of Bern at 3 sites in Switzerland.
Trial summary
The SCCSS-FollowUp is a national, multicenter cohort study designed to investigate late effects in childhood cancer survivors in a prospective and longitudinal way. The study is embedded in regular follow-up care and inclusion in the study takes place in a step-wise approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Late Effect, Childhood Cancer
- What is being tested?
- Physical examination, diagnostic tests, laboratory tests and Personal history, questionnaire
- How many people
- 3,000 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 20 Jun 2022to 1 Jan 2071
- 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: Childhood cancer survivors, who were diagnosed in a Swiss pediatric oncology clinic at age <21 years from 1976 onward and who completed their cancer treatment. Survivors are eligible to participate to the study from the first day after treatment completion, but can also enter the study later.
Who may be able to join
- Registered in the Childhood Cancer Registry (ChCR) or treated and followed-up in a Swiss pediatric oncology (SPOG) clinic, but not registered in the ChCR because of residency in neighboring countries
- Diagnosed at age 0 - 20 years
- Childhood cancer treatment completed
- All age categories at time of inclusion in the study (children, adolescents, adults)
- Written informed consent
Who cannot join
- Childhood cancer survivors in a palliative or relapsed situation where no follow-up examinations are foreseen.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University Childen's Hospital Basel
Basel
Nicolas X von der Weid, MD
Nicolas X von der Weid, MD
- Recruiting
University Children's Hospital Bern
Bern
Philipp Latzin, MD
Philipp Latzin, MD
- Recruiting
University Hospital Geneva
Geneva
Marc Ansari, MD
Marc Ansari, MD
About this study
The SCCSS-FollowUp is a national, multicenter cohort study designed to investigate late effects in childhood cancer survivors in a prospective and longitudinal way. The study is embedded in regular follow-up care and inclusion in the study takes place in a step-wise approach. The investigators collect data from clinical examinations, laboratory and functional tests, and questionnaires to learn more about late effects of childhood cancer treatments.
Read the detailed description
Background: Survival after childhood cancer has increased substantially over the last decades. In Switzerland, 10-year survival now exceeds 85%. This results in increasing numbers of childhood cancer survivors - estimated 6,600 survivors currently in Switzerland. Due to the cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffer from late effects. As survivors of childhood cancer have decades of life ahead, it is of special interest to minimize potentially avoidable chronic diseases, impaired quality of life, deaths, and health care costs. There is a need to assess clinical data prospectively in a standardized way across clinics to study late effects on a national level. Such data are currently not available in Switzerland and the SCCSS-FollowUp aims to fill this gap.
Objectives: The SCCSS-FollowUp assesses the prevalence of late effects through risk-adapted medical examinations (in accordance with international guidelines and evidence), identifies CCS with asymptomatic late effects through functional testing, e.g. echocardiography or lung function testing, standardizes clinical follow-up examinations in CCS in Switzerland, and collects follow-up data in a longitudinal way. The SCCSS-FollowUp also investigates sociodemographic, treatment, lifestyle, and clinical risk factors for late effect development.
Methods: The SCCSS-FollowUp recruits eligible childhood cancer survivors in a stepwise approach by identifying CCS at risk because of specific treatment modalities (e.g. exposure to anthracyclines or thoracic irradiation). The investigators ask eligible survivors for participation. Those who consent receive before or during the next follow-up visits focused questionnaires. The questionnaires are short and focus on one organ system, but participants can receive different questionnaires at subsequent visits. The data generated during the follow-up visits, such as clinical examination, functional and laboratory test results, and the completed questionnaires are entered in the SCCSS-FollowUp database. The examinations and tests are performed in a standardized way in all participating clinics and according to follow-up guidelines or other evidence-based literature.
Rationale and significance:
The data collected within the SCCSS-FollowUp allow research on late effects on a national level and based on objective clinical data obtained during routine care. The SCCSS-FollowUp helps to learn more about late effects, especially subclinical damage, which are not detectable by questionnaire only. Early detection of these late effects and timely treatment can prevent and mitigate further deterioration. Furthermore, the SCCSS-FollowUp helps to assess risk factors for late effects development which can be used to amend cancer treatment in future patients. The SCCSS-FollowUp thus helps to improve the health of current and future childhood cancer survivors.
- Conditions
- Late Effect, Childhood Cancer
- Being tested
- Physical examination, diagnostic tests, laboratory tests, Personal history, questionnaire
- Keywords
- Childhood Cancer, Late Effects, Survivor
- 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 depending on examined organ system (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels).
Personal history, questionnaireOther
Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of organ-specific late effects (example of pulmonary late effects)
Number of people with cough or shortness of breath when at risk for pulmonary late effects
Measured: At baseline
Signs of organ-specific late effects (example of pulmonary late effects)
Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects
Measured: At baseline
Tests to assess organ-specific late effects (example of pulmonary late effects)
Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects
Measured: At baseline
Secondary outcomes (7)
Symptoms of organ-specific late effects (example of pulmonary late effects)
Number of people with cough or shortness of breath when at risk for pulmonary late effects
Measured: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Signs of organ-specific late effects (example of pulmonary late effects)
Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects
Measured: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Tests to assess organ-specific late effects (example of pulmonary late effects)
Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects
Measured: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Treatment-related risk factors for late effects
Cumulative dose of chemotherapeutic agents or radiotherapy, exposure to surgery and hematopoietic stem cell transplantation for each participant (not exhaustive)
Measured: At baseline
Sociodemographic and socioeconomic characteristics potentially associated with late effects
Collection of information on age at diagnosis, time since diagnosis, and gender for each participant (not exhaustive)
Measured: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Lifestyle factors potentially associated with late effects
Collection of information on smoking status, physical activity, and body mass index for each participant (not exhaustive)
Measured: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Comorbidities potentially associated with late effects
Collection of information on arterial hypertension or obesity for each participant (not exhaustive)
Measured: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start20 Jun 2022
- Primary completion1 Jan 2071 (estimated)
- Study completion1 Jan 2071 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Late EffectStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia E Kuehni, MD, Principal investigator, Institute of Social and Preventive Medicine, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04732273
- Sponsor's protocol ID
- 2019-00739
- Other IDs
- 2019
- Acronym
- SCCSS-FU
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2021
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zarkovic M, Schindera C, Waespe N, Usemann J, Schneider C, Mornand A, Ansari M, Latzin P, Kuehni CE. Multiple breath washout for pulmonary function assessment in young childhood cancer survivors: a multicenter study. Ann Am Thorac Soc. 2026 Nov 1;23(11):1696-1705. doi: 10.1093/annalsats/aaoag113.
PubMed 42050876Zarkovic M, Schindera C, Sommer G, Schneider C, Usemann J, Otth M, Luer S, Ansari M, Latzin P, Kuehni CE. Assessing Pulmonary Function in Children and Adolescents After Cancer Treatment: Protocol for a Multicenter Cohort Study (Swiss Childhood Cancer Survivor Study FollowUp-Pulmo). JMIR Res Protoc. 2025 Apr 8;14:e69743. doi: 10.2196/69743.
PubMed 40198919
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)
- ClinicalTrials.gov ID
- NCT04732273
- Acronym / sponsor ID
- SCCSS-FU / 2019-00739
- Conditions
- Late Effect, Childhood Cancer
- Keywords
- Childhood Cancer, Late Effects, Survivor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 1 Jan 2071 (estimated)
- Study completion
- 1 Jan 2071 (estimated)
- First posted
- 1 Feb 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 SCCSS-FollowUp is a national, multicenter cohort study designed to investigate late effects in childhood cancer survivors in a prospective and longitudinal way. The study is embedded in regular follow-up care and inclusion in the study takes place in a step-wise approach. The investigators collect data from clinical examinations, laboratory and functional tests, and questionnaires to learn more about late effects of childhood cancer treatments.
Detailed description
Background: Survival after childhood cancer has increased substantially over the last decades. In Switzerland, 10-year survival now exceeds 85%. This results in increasing numbers of childhood cancer survivors - estimated 6,600 survivors currently in Switzerland. Due to the cancer treatment or the cancer itself, a large part of the childhood cancer survivors suffer from late effects. As survivors of childhood cancer have decades of life ahead, it is of special interest to minimize potentially avoidable chronic diseases, impaired quality of life, deaths, and health care costs. There is a need to assess clinical data prospectively in a standardized way across clinics to study late effects on a national level. Such data are currently not available in Switzerland and the SCCSS-FollowUp aims to fill this gap.
Objectives: The SCCSS-FollowUp assesses the prevalence of late effects through risk-adapted medical examinations (in accordance with international guidelines and evidence), identifies CCS with asymptomatic late effects through functional testing, e.g. echocardiography or lung function testing, standardizes clinical follow-up examinations in CCS in Switzerland, and collects follow-up data in a longitudinal way. The SCCSS-FollowUp also investigates sociodemographic, treatment, lifestyle, and clinical risk factors for late effect development.
Methods: The SCCSS-FollowUp recruits eligible childhood cancer survivors in a stepwise approach by identifying CCS at risk because of specific treatment modalities (e.g. exposure to anthracyclines or thoracic irradiation). The investigators ask eligible survivors for participation. Those who consent receive before or during the next follow-up visits focused questionnaires. The questionnaires are short and focus on one organ system, but participants can receive different questionnaires at subsequent visits. The data generated during the follow-up visits, such as clinical examination, functional and laboratory test results, and the completed questionnaires are entered in the SCCSS-FollowUp database. The examinations and tests are performed in a standardized way in all participating clinics and according to follow-up guidelines or other evidence-based literature.
Rationale and significance:
The data collected within the SCCSS-FollowUp allow research on late effects on a national level and based on objective clinical data obtained during routine care. The SCCSS-FollowUp helps to learn more about late effects, especially subclinical damage, which are not detectable by questionnaire only. Early detection of these late effects and timely treatment can prevent and mitigate further deterioration. Furthermore, the SCCSS-FollowUp helps to assess risk factors for late effects development which can be used to amend cancer treatment in future patients. The SCCSS-FollowUp thus helps to improve the health of current and future childhood cancer survivors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Childhood cancer survivors, who were diagnosed in a Swiss pediatric oncology clinic at age <21 years from 1976 onward and who completed their cancer treatment. Survivors are eligible to participate to the study from the first day after treatment completion, but can also enter the study later.
Key inclusion criteria (5 listed)
- Registered in the Childhood Cancer Registry (ChCR) or treated and followed-up in a Swiss pediatric oncology (SPOG) clinic, but not registered in the ChCR because of residency in neighboring countries
- Diagnosed at age 0 - 20 years
- Childhood cancer treatment completed
- All age categories at time of inclusion in the study (children, adolescents, adults)
- Written informed consent
Key exclusion criteria (1 listed)
- Childhood cancer survivors in a palliative or relapsed situation where no follow-up examinations are foreseen.
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 depending on examined organ system (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels). | Other | – |
| Personal history, questionnairePersonal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing. | Other | – |
Primary outcome
Symptoms of organ-specific late effects (example of pulmonary late effects)
Time frame: At baseline
Number of people with cough or shortness of breath when at risk for pulmonary late effects
Signs of organ-specific late effects (example of pulmonary late effects)
Time frame: At baseline
Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects
Tests to assess organ-specific late effects (example of pulmonary late effects)
Time frame: At baseline
Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects
7 secondary outcomes
Symptoms of organ-specific late effects (example of pulmonary late effects)
Time frame: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Signs of organ-specific late effects (example of pulmonary late effects)
Time frame: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Tests to assess organ-specific late effects (example of pulmonary late effects)
Time frame: 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Treatment-related risk factors for late effects
Time frame: At baseline
Sociodemographic and socioeconomic characteristics potentially associated with late effects
Time frame: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Lifestyle factors potentially associated with late effects
Time frame: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
Comorbidities potentially associated with late effects
Time frame: At baseline, 1 year after recruitment, 2 years after recruitment, 3 years after recruitment, 4 years after recruitment, 5 years after recruitment, 10 years after recruitment, 15 years after recruitment, 20 years after recruitment
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 23 Sep 2025.
- Derived from this study: PubMed 42050876Zarkovic M, Schindera C, Waespe N, Usemann J, Schneider C, Mornand A, Ansari M, Latzin P, Kuehni CE. Multiple breath washout for pulmonary function assessment in young childhood cancer survivors: a multicenter study. Ann Am Thorac Soc. 2026 Nov 1;23(11):1696-1705. doi: 10.1093/annalsats/aaoag113.
- Derived from this study: PubMed 40198919Zarkovic M, Schindera C, Sommer G, Schneider C, Usemann J, Otth M, Luer S, Ansari M, Latzin P, Kuehni CE. Assessing Pulmonary Function in Children and Adolescents After Cancer Treatment: Protocol for a Multicenter Cohort Study (Swiss Childhood Cancer Survivor Study FollowUp-Pulmo). JMIR Res Protoc. 2025 Apr 8;14:e69743. doi: 10.2196/69743.
- 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.
Claudia E Kuehni, MD principal investigator
Institute of Social and Preventive Medicine, University of Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Late Effect and Childhood Cancer, run by University of Bern at 3 sites 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 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Claudia E Kuehni, MD (+41 31 631 35 07, claudia.kuehni@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of organ-specific late effects (example of pulmonary late effects) (time frame: At baseline). The study lists 3 primary outcomes in all. 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 NCT04732273, which also lists 2 linked publications.
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 23 Sep 2025.