The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Bern
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Childhood cancer survivors in a palliative or relapsed situation where no follow-up examinations are foreseen.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Physical examination, diagnostic tests, laboratory tests
Other interventionPhysical 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
Other interventionPersonal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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
Time frame
At baseline2
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
Time frame
At baseline3
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
Time frame
At baselineSecondary outcomes
1
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
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 recruitment2
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
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 recruitment3
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
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 recruitment4
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)
Time frame
At baselineSponsors and contacts
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Source ClinicalTrials.gov