Primary objectives1. To investigate prospectively the prevalence of cardiovascular damage due to cancer treatment and it*s change over time.2. To investigate markers of early and late toxicity of cardiovascular damage due to cardiotoxic treatment.…
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Prevalence of subclinical cardiac damage (diagnosed by echocardiography as
either systolic, diastolic or combined
dysfunction)
2. Prevalence of cardiovascular risk factors (blood pressure, vascular wall
changes, body composition and
metabolic syndrome)
3. Changes in intima media thickness in carotid-/femoral arteries after
treatment with anthracyclines and/or
thoracal/neckradiation.
Secondary outcome
NA
Background summary
In the last 15 years it has become clear that long-term survivors of childhood
cancer, especially those treated with radiotherapy on the mediastinum and/or
anthracyclines have a significantly increased risk of developing cardiovascular
late effects. More insight into the underlying pathophysiological mechanisms,
the relationship between cardiovascular risks factors and the development of
cardiovascular damage is needed to design suitable intervention strategies.
Study objective
Primary objectives
1. To investigate prospectively the prevalence of cardiovascular damage due to
cancer treatment and it*s change
over time.
2. To investigate markers of early and late toxicity of cardiovascular damage
due to cardiotoxic treatment.
Secundary objectives
1. To study cardiovascular risk factors during cancer treatment (like
cardiovascular damage, body composition and
genetic susceptibility).
2. To generate a database of childhood cancer survivors with the purpose of
prospective cardiovascular late effects
studies over prolonged periods of time
Study design
This is a prospective longitudinal non-randomised cohort study in newly
diagnosed children who will be treated for cancer at the Pediatric Oncology
Center Groningen.
Additional inclusion criteria are: age between 0 and 18 years at start of
treatment, being able to understand the Dutch study information (patient and/or
parent), and willingness to give written informed consent.
Study burden and risks
The non-invasive tests will be performed during treatment and routine follow-up
visits and are partial standard care. As far as known no adverse events are
linked to the described study procedures. As soon as insight has been gained
into the prevalence of treatment induced cardiovascular disease, its
progression and the role of additional risk factors, tools can be developed for
secondary prevention and eventually primary prevention. Efficacious prevention
or alleviation of cardiovascular disease due to cancer treatment may reduce
treatment-related morbidity and mortality in long-term childhood cancer
survivors and thus benefit their quality of life.
Hanzeplein 1
Groningen
NL
Hanzeplein 1
Groningen
NL
Listed location countries
Age
Inclusion criteria
newly diagnosed childhood cancer patients
age 0-18 years
written informed consent
Exclusion criteria
inadequate knowledge of the dutch language for reading the information and writing informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28905.042.09 |