A case-cohort study to identify risk factors for cardiovascular disease in testicular cancer survivors

Completed

Conditions: hartfalen, metabool syndroom
cardiovascular disease in testicular cancer survivors
10011082
10038597

Registration Number: NL-OMON40337

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 900

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>We will evaluate the independent and joint effects of disease- and treatment<br /><br>characteristics and the (components of the) metabolic syndrome on development<br /><br>of cardiovascular disease. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are biochemical markers (a.o. vWF, urinary<br /><br>albumin/creatinine ratio, hs-CRP), hypogonadism (testosterone, LH, FSH,<br /><br>estradiol levels), presence of relevant polymorphisms in genomic DNA, telomere<br /><br>length, and circulating platinum levels (only in participants treated with<br /><br>chemotherapy); in addition quality of life will be assessed. In the UMCG<br /><br>additional measurements for subclinical vascular damage will be assessed by<br /><br>evaluating intima media thickness (IMT), arterial stifness and skin<br /><br>autofluorescence (SAF) as measure of advanced glycation end products (AGEs). </p><br>