Young Survivors at Kantonsspital Aarau, Switzerland

August 16, 2022 updated by: Katrin Scheinemann, Kantonsspital Aarau

Young Survivors at Kantonsspital Aarau, Switzerland - A Standardized Assessment of Long-Term and Late-Onset Health Events in Survivors of Childhood and Adolescent Cancer

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.

Study Overview

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Aarau, Switzerland
        • Recruiting
        • Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
        • Principal Investigator:
          • Katrin Scheinemann, MD
        • Sub-Investigator:
          • Maria Otth, MD
        • Contact:
        • Sub-Investigator:
          • Daniel Drozdov, MD
        • Sub-Investigator:
          • Claudia Huegli, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group A (largest part of the cohort)
Children, adolescents, and adults who are still in follow-up care (data are collected retrospectively until 2016 at the most)
Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.
Personal history on diagnosis, treatment, and socioeconomic factors
Group B (very small part of the cohort)
Children, adolescents, and adults who left follow-up care (data are collected retrospectively until 2016 at the most)
Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.
Personal history on diagnosis, treatment, and socioeconomic factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test results to assess organ-specific late effects (example of cardiac health)
Time Frame: at recruitment or 2016 onwards, whichever comes first
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction when at risk for cardiac late effects
at recruitment or 2016 onwards, whichever comes first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Test results to assess organ-specific late effects (example of cardiac health)
Time Frame: annually from recruitment or 2016 onwards, whichever comes first
Number of survivors with heart valve disorder, hypertension, left ventricular systolic dysfunction etc. when at risk for cardiac late effects
annually from recruitment or 2016 onwards, whichever comes first
Sociodemographic and socioeconomic characteristics (e.g. age at clinical examination, gender, education or working situation, living situation)
Time Frame: annually from recruitment or 2016 onwards, whichever comes first
annually from recruitment or 2016 onwards, whichever comes first
Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects
Time Frame: annually from recruitment or 2016 onwards, whichever comes first
annually from recruitment or 2016 onwards, whichever comes first
Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol)
Time Frame: at recruitment or 2016 onwards, whichever comes first
at recruitment or 2016 onwards, whichever comes first
Treatment-related data (e.g. cumulative doses of chemotherapy and radiotherapy, surgery, hematopoietic stem cell transplantation )
Time Frame: at recruitment or 2016 onwards, whichever comes first
at recruitment or 2016 onwards, whichever comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2021

Primary Completion (Anticipated)

March 15, 2071

Study Completion (Anticipated)

March 15, 2072

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

August 17, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • AO_2020-00012

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Cancer

Clinical Trials on Physical examination, diagnostic tests, laboratory tests

Subscribe