Clinical trial NCT04811794: Young Survivors at Kantonsspital Aarau, Switzerland
Official title: Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Childhood Cancer
Late Effects
Keywords: Childhood Cancer
Survivor
Late Effects
CTCAE
Lead sponsor: Kantonsspital Aarau
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all children, adolescents and adults who have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau and who have completed their treatment and have entered follow-up care.

Brief summary: The Young Survivors at Kantonsspital Aarau project assesses the prevalence and severity of late effects in survivors of childhood and adolescent cancer according to the modified CTCAE criteria prospectively. The clinical data are generated during regular follow-up care visits, the collection starts directly after completion of treatment and is longitudinally.

Detailed description: Background:

Around 250-300 children and adolescents below the age of 21 years are newly diagnosed with cancer in Switzerland every year. Research led to remarkable progress in survival in the last decades. The 10-year survival rate in Switzerland is currently 87%. Previous research showed that, depending on the treatment exposure, a high proportion of these survivors suffer from chronic medical conditions, so called late effects.

Many studies on late effects in former childhood cancer patients are based on retrospective data. However, this type of study design has unavoidable limitations, such as missing data, different coding and grading of severity of late effects, and the assessment at different time points. Therefore, we need prospectively collected data, including severity coding in a standardized way, to overcome these limitations.

Objectives:

The overarching aim of "Young Survivors at Kantonsspital Aarau, Switzerland" is to assess late effects in childhood cancer survivors prospectively and in a standardized way. These data will contribute to the increasing knowledge on long-term outcomes and late effects in the future. This new knowledge is important in order to be able to adapt and improve long-term follow-up care. In the longer term, survivors will benefit from this extensive and prospective data collection.

Methods:

"Young Survivors at Kantonsspital Aarau" has a registry-like design. Data produced during regular follow-up visits are collected in a comprehensive database and in a standardized way. We collect all information generated prospectively from start of the study onwards and retrospectively until January 2016. From 2016 onward, all medical records are kept electronically. We classify and grade the severity of late effects according to the modified National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.03). The outcome variables correspond to results from risk-stratified organ examinations, which are performed according to the Children's Oncology Group guidelines v5.0. The exposure variables correspond to information from the patients' medical history, including detailed information on cancer diagnosis and treatment. The data will be analyzed in an exposure- or organ system-driven approach. We start recruitment with patients diagnosed and treated at the Kantonsspital Aarau. The design of the study allows the inclusion of other clinics in the future.

Research and significance:

Research on late effects of former childhood cancer patients often relies on retrospective data collection, which is associated with unpreventable limitations. "Young Survivors at Kantonsspital Aarau" overcomes these limitations and additionally grades the severity of late effects in a standardized way. This allows us to analyze changes in severity of late effects over time, within and between survivors. This information will increase our knowledge on late effects and contribute to long-term follow-up care.

Eligibility criteria: Inclusion Criteria:

Group A:

Children and adolescents who:

* have been treated for cancer in the Division of Oncology-Hematology, Department of Pediatrics, at the Kantonsspital Aarau,
* have been diagnosed at age 0-18 years,
* are still in regular follow-up care at the Kantonsspital Aarau,
* have finished cancer treatment and entered follow-up care, and
* signed informed consent

Group B:

Adolescents and adults who:

* fulfill the same inclusion criteria as Group A
* are not in regular follow-up care anymore

Exclusion Criteria:

Childhood Cancer Survivors who:

* are in a palliative situation or
* have not given consent for further use of medical data

Primary outcomes:
measure: Test results to assess organ-specific late effects (example of cardiac health)
timeFrame: at recruitment or 2016 onwards, whichever comes first
Secondary outcomes:
measure: Test results to assess organ-specific late effects (example of cardiac health)
timeFrame: annually from recruitment or 2016 onwards, whichever comes first
measure: Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)
timeFrame: annually from recruitment or 2016 onwards, whichever comes first
measure: Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects
timeFrame: annually from recruitment or 2016 onwards, whichever comes first
measure: Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)
timeFrame: at recruitment or 2016 onwards, whichever comes first
measure: Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )
timeFrame: at recruitment or 2016 onwards, whichever comes first
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
Study officials:
References:
citation: Otth M, Drozdov D, Hugli C, Scheinemann K. 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. BMJ Open. 2021 Dec 3;11(12):e053749. doi: 10.1136/bmjopen-2021-053749.