Clinical trial NCT04732273: The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)
Official title: The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Late Effect
Childhood Cancer
Keywords: Childhood Cancer
Late Effects
Survivor
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood cancer survivors, who were diagnosed in a Swiss pediatric oncology clinic at age \<21 years from 1976 onward, who completed their cancer treatment, and are resident in Switzerland at time of study enrollment. Survivors are eligible to participate to the study from the first day after treatment completion, but can also enter the study later.

Brief 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. 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.

Eligibility criteria: This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a national, population-based cancer registry that includes all children and adolescents in Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid tumors or Langerhans cell histiocytosis.

Inclusion Criteria:

* Registered in the Childhood Cancer Registry (ChCR)
* Diagnosed at age 0 - 20 years
* Childhood cancer treatment completed
* All age categories at time of inclusion in the study (children, adolescents, adults)
* Resident in Switzerland at time of study participation
* Written informed consent

Exclusion criteria:

* Childhood cancer survivors in a palliative or relapsed situation where no follow-up examinations are foreseen.

Primary outcomes:
measure: Symptoms of organ-specific late effects (example of pulmonary late effects)
timeFrame: At baseline
measure: Signs of organ-specific late effects (example of pulmonary late effects)
timeFrame: At baseline
measure: Tests to assess organ-specific late effects (example of pulmonary late effects)
timeFrame: At baseline
Secondary outcomes:
measure: Symptoms of organ-specific late effects (example of pulmonary late effects)
timeFrame: 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
measure: Signs of organ-specific late effects (example of pulmonary late effects)
timeFrame: 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
measure: Tests to assess organ-specific late effects (example of pulmonary late effects)
timeFrame: 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
measure: Treatment-related risk factors for late effects
timeFrame: At baseline
measure: Sociodemographic and socioeconomic characteristics potentially associated with late effects
timeFrame: 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
measure: Lifestyle factors potentially associated with late effects
timeFrame: 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
measure: Comorbidities potentially associated with late effects
timeFrame: 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
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Childen's Hospital Basel
city: Bern
country: Switzerland
facility: University Children's Hospital Bern
city: Geneva
country: Switzerland
facility: University Hospital Geneva
Study officials:
affiliation: Institute of Social and Preventive Medicine, University of Bern
name: Claudia E Kuehni, MD
role: PRINCIPAL_INVESTIGATOR
References: