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

Childhood Cancer Clinical Trial

— SCCSS-FU  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732273
• Other study ID #: 2019-00739
• Status: Recruiting
• Start date: June 20, 2022
• Est. completion date: January 1, 2071

Study information

• Verified date: June 2024
• Source: University of Bern
• Contact: Claudia E Kuehni, MD
• Phone: +41 31 631 35 07
• Email: claudia.kuehni[@]unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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. The investigators collect data from clinical examinations, laboratory and functional tests, and questionnaires to learn more about late effects of childhood cancer treatments.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: January 1, 2071
• Est. primary completion date: January 1, 2071
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Cancer
• Late Effect

Intervention

Other:
• Physical examination, diagnostic tests, laboratory tests
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, questionnaire
Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.

Locations

Country	Name	City	State
Switzerland	University Childen's Hospital Basel	Basel
Switzerland	University Children's Hospital Bern	Bern
Switzerland	University Hospital Geneva	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University of Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline
Primary	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	At baseline
Primary	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	At baseline
Secondary	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	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
Secondary	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	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
Secondary	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	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
Secondary	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)	At baseline
Secondary	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)	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
Secondary	Lifestyle factors potentially associated with late effects	Collection of information on smoking status, physical activity, and body mass index for each participant (not exhaustive)	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
Secondary	Comorbidities potentially associated with late effects	Collection of information on arterial hypertension or obesity for each participant (not exhaustive)	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