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).

Physical examination, diagnostic tests, laboratory tests

Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.

Personal history, questionnaire

Claudia E Kuehni, MD

Maria Otth, MD

Nicolas X von der Weid, MD

Jochen Rössler, MD

Marc Ansari, MD

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.

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.

The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)

Number of people with cough or shortness of breath when at risk for pulmonary late effects

Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects

Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects

Cumulative dose of chemotherapeutic agents or radiotherapy, exposure to surgery and hematopoietic stem cell transplantation for each participant (not exhaustive)

Collection of information on age at diagnosis, time since diagnosis, and gender for each participant (not exhaustive)

Collection of information on smoking status, physical activity, and body mass index for each participant (not exhaustive)

Collection of information on arterial hypertension or obesity for each participant (not exhaustive)

University of Bern

Children, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most)

Children, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most)

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 history on diagnosis, treatment, and socioeconomic factors

Personal history

Katrin Scheinemann, MD

Daniel Drozdov, MD

Claudia Huegli, MD

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.

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.

Young Survivors at Kantonsspital Aarau, Switzerland

Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer

Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects

Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction etc. when at risk for cardiac late effects

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)	NCT04732273	Late Effect Childhood Cance...	Physical examin... Personal histor...	-	University of Bern
The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)	NCT04732273	Late Effect Childhood Cance...	Physical examin... Personal histor...	-	University of Bern
Young Survivors at Kantonsspital Aarau, Switzerland	NCT04811794	Childhood Cance... Late Effects	Physical examin... Personal histor...	-	Kantonsspital Aarau

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