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

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer; Late Effect
• Intervention / Treatment: Other: Physical examination, diagnostic tests, laboratory tests; Other: Personal history, questionnaire

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 Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Claudia E Kuehni, MD; Phone Number: +41 31 631 35 07; Email: claudia.kuehni@ispm.unibe.ch
• Study Contact Backup: Name: Maria Otth, MD; Phone Number: +41 31 631 37 71; Email: maria.otth@ispm.unibe.ch

Study Locations

• Switzerland
  • Basel, Switzerland
    • Recruiting
    • University Childen's Hospital Basel
    • Contact: Nicolas X von der Weid, MD
    • Principal Investigator: Nicolas X von der Weid, MD
  • Bern, Switzerland
    • Recruiting
    • University Children's hospital Bern
    • Contact: Jochen Rössler, MD
    • Principal Investigator: Jochen Rössler, MD
  • Geneva, Switzerland
    • Recruiting
    • University Hospital Geneva
    • Contact: Marc Ansari, MD
    • Principal Investigator: Marc Ansari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Claudia E Kuehni, MD, Institute of Social and Preventive Medicine, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Estimated): January 1, 2071
• Study Completion (Estimated): January 1, 2071

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 26, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Childhood Cancer; Survivor; Late Effects
• Other Study ID Numbers: 2019-00739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No