JOURNAL ONKOLOGIE – STUDIE

Young Survivors at Kantonsspital Aarau, Switzerland

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT04811794

Studienbeginn:
März 2021

Letztes Update:
17.08.2022

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Kantonsspital Aarau

Collaborator:
-

Kontakt

Katrin Scheinemann, MD
Kontakt:
Phone: +41628384909
E-Mail: katrin.scheinemann@ksa.ch» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Division of Oncology - Hematology, Department of Pediatrics, Kantonsspital Aarau
Aarau
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Katrin Scheinemann, MD
Phone: +41628384909
E-Mail: katrin.scheinemann@ksa.ch» Ansprechpartner anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. 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

Secondary outcome:

1. 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

2. 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)

3. Comorbidities (e.g. arterial hypertension, obesity) as risk factors for late effects (Time Frame - annually from recruitment or 2016 onwards, whichever comes first)

4. Diagnosis-related data (e.g. age at diagnosis, diagnosis, disease stage, treatment protocol) (Time Frame - at recruitment or 2016 onwards, whichever comes first)

5. 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)

Studien-Arme

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)
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)

Geprüfte Regime

Physical examination, diagnostic tests, laboratory tests:
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:
Personal history on diagnosis, treatment, and socioeconomic factors

Quelle: ClinicalTrials.gov

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