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JOURNAL ONKOLOGIE – STUDIE
SCCSS-FU

The Swiss Childhood Cancer Survivor Study - Follow-up (SCCSS-FollowUp)

Rekrutierend

NCT-Nummer:
NCT04732273

Studienbeginn:
Januar 2021

Letztes Update:
01.02.2021

Wirkstoff:
-

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
University of Bern

Collaborator:
-

Studienleiter

Claudia E Kuehni, MD
Principal Investigator
Institute of Social and Preventive Medicine, University of Bern

Kontakt

Studienlocations
(3 von 3)

Studien-Informationen

Detailed Description:

Background: Survival after childhood cancer has increased substantially over the last

decades. In Switzerland, 10-year survival now exceeds 85%. This results in increasing numbers

of childhood cancer survivors - estimated 6,600 survivors currently in Switzerland. Due to

the cancer treatment or the cancer itself, a large part of the childhood cancer survivors

suffer from late effects. As survivors of childhood cancer have decades of life ahead, it is

of special interest to minimize potentially avoidable chronic diseases, impaired quality of

life, deaths, and health care costs. There is a need to assess clinical data prospectively in

a standardized way across clinics to study late effects on a national level. Such data are

currently not available in Switzerland and the SCCSS-FollowUp aims to fill this gap.

Objectives: The SCCSS-FollowUp assesses the prevalence of late effects through risk-adapted

medical examinations (in accordance with international guidelines and evidence), identifies

CCS with asymptomatic late effects through functional testing, e.g. echocardiography or lung

function testing, standardizes clinical follow-up examinations in CCS in Switzerland, and

collects follow-up data in a longitudinal way. The SCCSS-FollowUp also investigates

sociodemographic, treatment, lifestyle, and clinical risk factors for late effect

development.

Methods: The SCCSS-FollowUp recruits eligible childhood cancer survivors in a stepwise

approach by identifying CCS at risk because of specific treatment modalities (e.g. exposure

to anthracyclines or thoracic irradiation). The investigators ask eligible survivors for

participation. Those who consent receive before or during the next follow-up visits focused

questionnaires. The questionnaires are short and focus on one organ system, but participants

can receive different questionnaires at subsequent visits. The data generated during the

follow-up visits, such as clinical examination, functional and laboratory test results, and

the completed questionnaires are entered in the SCCSS-FollowUp database. The examinations and

tests are performed in a standardized way in all participating clinics and according to

follow-up guidelines or other evidence-based literature.

Rationale and significance:

The data collected within the SCCSS-FollowUp allow research on late effects on a national

level and based on objective clinical data obtained during routine care. The SCCSS-FollowUp

helps to learn more about late effects, especially subclinical damage, which are not

detectable by questionnaire only. Early detection of these late effects and timely treatment

can prevent and mitigate further deterioration. Furthermore, the SCCSS-FollowUp helps to

assess risk factors for late effects development which can be used to amend cancer treatment

in future patients. The SCCSS-FollowUp thus helps to improve the health of current and future

childhood cancer survivors.

Ein-/Ausschlusskriterien

This prospective cohort study is nested within the Childhood Cancer Registry (ChCR), a

national, population-based cancer registry that includes all children and adolescents in

Switzerland who were diagnosed with cancer at age 0-20 years. It includes patients

diagnosed with leukemia, lymphoma, central nervous system tumors, and malignant solid

tumors or Langerhans cell histiocytosis.

Inclusion Criteria:

- Registered in the Childhood Cancer Registry (ChCR)

- Diagnosed at age 0 - 20 years

- Childhood cancer treatment completed

- All age categories at time of inclusion in the study (children, adolescents, adults)

- Resident in Switzerland at time of study participation

- Written informed consent

Exclusion criteria:

- Childhood cancer survivors in a palliative or relapsed situation where no follow-up

examinations are foreseen.

Studien-Rationale

Primary outcome:

1. Symptoms of organ-specific late effects (example of pulmonary late effects) (Time Frame - At baseline):
Number of people with cough or shortness of breath when at risk for pulmonary late effects

2. Signs of organ-specific late effects (example of pulmonary late effects) (Time Frame - At baseline):
Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects

3. Tests to assess organ-specific late effects (example of pulmonary late effects) (Time Frame - At baseline):
Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects

Secondary outcome:

1. Symptoms of organ-specific late effects (example of 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 recruitment):
Number of people with cough or shortness of breath when at risk for pulmonary late effects

2. Signs of organ-specific late effects (example of 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 recruitment):
Number of people with signs of disturbed breathing or abnormal breathing sounds when at risk for pulmonary late effects

3. Tests to assess organ-specific late effects (example of 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 recruitment):
Number of people with abnormal pulmonary function testing (e.g. spirometry, body plethysmography) when at risk for pulmonary late effects

4. Treatment-related risk factors for late effects (Time Frame - At baseline):
Cumulative dose of chemotherapeutic agents or radiotherapy, exposure to surgery and hematopoietic stem cell transplantation for each participant (not exhaustive)

5. Sociodemographic and socioeconomic characteristics potentially associated with late effects (Time Frame - At baseline, 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 recruitment):
Collection of information on age at diagnosis, time since diagnosis, and gender for each participant (not exhaustive)

6. Lifestyle factors potentially associated with late effects (Time Frame - At baseline, 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 recruitment):
Collection of information on smoking status, physical activity, and body mass index for each participant (not exhaustive)

7. Comorbidities potentially associated with late effects (Time Frame - At baseline, 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 recruitment):
Collection of information on arterial hypertension or obesity for each participant (not exhaustive)

Geprüfte Regime

  • Physical examination, diagnostic tests, laboratory tests:
    Physical 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:
    Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.

Quelle: ClinicalTrials.gov


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