Young Survivors at KSA: registry for standardised assessment of long-term and late-onset health events in survivors of childhood and adolescent cancer—a study protocol

Abstract

IntroductionA high proportion of survivors of childhood and adolescent cancer experience chronic medical conditions — late effects. Most studies on late effects have a retrospective or questionnaire-based design, which leads to unavoidable limitations such as missing data or different severity coding and grading of late effects. We, therefore, need prospective data, including standardised severity coding and grading. ‘Young Survivors at KSA’ aims to close this gap by assessing frequency, severity, risk factors and longitudinal changes of late effects in childhood cancer survivors prospectively and in a standardised way.Methods and analysisWithin the ‘Young Survivors at KSA’ registry, we collect data from regular follow-up visits in a comprehensive database prospectively and repeatedly from start of the study and retrospectively at most until January 2016. We classify and grade the severity of late effects according to the Common Terminology Criteria for Adverse Events version 4.0 modified by Hudson et al. The outcome variables correspond to results from risk-stratified organ examinations, performed according to the Children’s Oncology Group guidelines version 5.0 and the recommendations by the International Guideline Harmonization Group. We collect the exposure variables from the patients’ medical history, including detailed information on cancer diagnosis and treatment. We analyse the data in an exposure-driven and organ system-driven approach. We start recruitment with patients treated at the Kantonsspital Aarau, Switzerland. However, our design allows the inclusion of additional national centres later.Ethics and dissemination‘Young Survivors at KSA’ is approved by the Ethikkommission Nordwest- und Zentralschweiz, reference number AO_2020–00012. The results of this study will be presented at scientific meetings, including meetings with childhood cancer survivors and published in peer-reviewed and if possible open access journals. New insights gained from the study will be used directly in clinical practice.Trial registration numberClinicalTrials.gov NCT04811794; https://clinicaltrials.gov/ct2/show/study/NCT04811794

Feasibility of a registry for standardized assessment of long-term and late-onset health events in survivors of childhood and adolescent cancer

“…The detailed information on treatment exposure gathered in the survivorship care plan are used for the "Young Survivors at KSA" registry. These data are entered manually in the registry-specific electronic database (REDCap) 13 , 14 (details on the database is available in the study protocol 11 ). Based on the modified CTCAE criteria, medical information on 15 organ systems: auditory, cardiovascular, endocrine, gastrointestinal, hematological, hepatobiliary, immunological, infectious, pulmonary, musculoskeletal, neurological, neurocognitive, renal/urinary tract, reproductive/genital tract and ocular/visual are additionally entered in the database 10 .…”

“…Data extraction and entry was performed manually by one author and spot check verified by another author. If an incorrect data entry was noticed, it was corrected and all data from the respective year were checked (details on methods is available in the study protocol 11 ).…”

“…The “Young Survivors at KSA” registry was approved by the cantonal ethics committee EKNZ (AO_2020-00012), is registered on ClinicalTrials.gov (NCT04811794), was conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice, and written informed consent was obtained from all participants 11 , 15 , 16 . For this feasibility study, only the information on organ function from the most recent follow-up visit was analyzed.…”

“…Hudson et al 10 adapted the CTCAE criteria to meet the special requirements of CCSs. We therefore incorporated these modified CTCAE criteria in the “Young Survivor at KSA (Kantonsspital Aarau)” registry 11 . The "Young Survivors at KSA" registry collects information on treatment exposures that are known to or might cause chronic medical conditions in CCSs.…”

“…It additionally gathers information retro- and prospectively on medical conditions of organ systems at risk based on the COG and IGHG guidelines in a standardized way by using the modified CTCAE criteria. The registry allows to assess the frequency, severity, and longitudinal changes of these medical conditions over time 11 . The primary purpose of this study is to assess the feasibility of performing the data collection during regular follow-up care and to describe the first 50 survivors randomly recruited in the registry.…”