The aim of this study is to identify risk factors for development of cardiovascular disease after TC treatment.
ID
Source
Brief title
Condition
- Other condition
- Coronary artery disorders
- Reproductive neoplasms male malignant and unspecified
Synonym
Health condition
hartfalen, metabool syndroom
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
We will evaluate the independent and joint effects of disease- and treatment
characteristics and the (components of the) metabolic syndrome on development
of cardiovascular disease.
Secondary outcome
Secondary study parameters are biochemical markers (a.o. vWF, urinary
albumin/creatinine ratio, hs-CRP), hypogonadism (testosterone, LH, FSH,
estradiol levels), presence of relevant polymorphisms in genomic DNA, telomere
length, and circulating platinum levels (only in participants treated with
chemotherapy); in addition quality of life will be assessed. In the UMCG
additional measurements for subclinical vascular damage will be assessed by
evaluating intima media thickness (IMT), arterial stifness and skin
autofluorescence (SAF) as measure of advanced glycation end products (AGEs).
Background summary
Testicular cancer (TC) is a rare disease, which mostly affects young men aged
15-35 years. Their life expectancy has greatly improved due to the introduction
of platinum-containing chemotherapy for disseminated TC in the late 1970s.
Given the good prognosis of TC nowadays, prevention or early detection of late
adverse effects of TC treatment has become increasingly important. Current
literature suggests that TC treatment, and specifically exposure to platinum
agents, is associated with increased risk of cardiovascular morbidity and
mortality. The precise role of treatment components like platinum in the
pathogenesis of cardiometabolic changes and cardiovascular disease (CVD)
warrants further investigation, since it is not known if CVD develops through
direct platinum-induced damage of the vascular wall or by mediation through
cardiometabolic changes. A more profound insight into pathophysiologic
mechanisms and identification of risk factors for CVDs is needed to facilitate
development of preventive strategies and to optimize survivorship care.
Study objective
The aim of this study is to identify risk factors for development of
cardiovascular disease after TC treatment.
Study design
A multicenter case-cohort study will be performed. We will collect detailed
diagnostic- and treatment data on TC and on (risk factors for) CVD for all
participants and will invite them to fill in a questionnaire and to donate
blood samples for DNA analysis, after written informed consent. Patients who
were younger than 40 years at TC diagnosis and younger than 75 years at moment
of study contact will be asked to participate in the cardiometabolic risk
inventory sub study. For this, participants have to undergo a basic study
assessment consisting of physical examination, venapuncture and handing in a
morning urine sample. This assessment can be performed at the participating
hospital, their general practitioner or at a home visit by a member of our
research team. Additional (non-invasive) cardiovascular function measurements
are only performed in the UMCG.
Study burden and risks
The nature and extent of the burden associated with participation is estimated
as low. Filling in questionnaires takes 15-30 minutes. If patients are willing
to participate in DNA analysis, they have to bring a single visit at their
general practitioner for a vena puncture. A sub study visit takes approximately
30 minutes. The additional and optional cardiovascular function measurements
(only in the UMCG) will prolong the visit with another 30 minutes. Venapuncture
is the only invasive procedure, with low risk of adverse effects. Participants
will be offered to have measurements performed during a visit to their general
practitioner or a home visit to lower the burden of study participation. This
study will provide more knowledge on determinants for the development of
cardiovascular events among TC survivors. As a result we will know which
factors to observe during follow-up and how to detect early cardiovascular
toxicity before severe events occur. With these data rational intervention
strategies will be developed.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
1) All invited patients have to meet the following criteria:
-Alive
-TC diagnosis between 01-01-1976 to 31-12-2007
-TC treatment center: UMCG, NKI/AVL, Erasmus MC, UMCN, LUMC
-Younger than 50 years of age at TC diagnosis;2A) Cases have to fulfill, beside the aforementioned criteria, the following criteria:
-Diagnosed with either myocardial infarction (MI), proven coronary artery disease (CAD) (CTCAE-4 grade 2 or higher) or congestive heart failure (CHF) (CTCAE-4 grade 2 or higher).
-No medical history of CVD before diagnosis of TC;2B) In order to be eligible to participate in the cardiometabolic risk inventory study (and to be invited to a study assessment), a subject must meet, next to the criteria mentioned in *1)*, the following inclusion criteria:
Cases and member of subcohort:
-Younger than 40 years of age at TC diagnosis
-Younger than 75 years of age at moment of inclusion
-Written informed consent
Exclusion criteria
- Mental disorder (no informed consent available)
- Presence of active malignant disease
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 | NL45655.042.13 |
| Other | wordt geregistreerd op clinicaltrials.gov, nummer volgt |