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

A case-cohort study to identify risk factors for cardiovascular disease in testicular cancer survivors - TACkLE-study - Tackling Adverse Chemotherapy-associated Late Effects

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40337

Enrollment

900

Registered

2014-06-18

Start date

2014-07-09

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hartfalen, metabool syndroom cardiovascular disease in testicular cancer survivors

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Mental disorder (no informed consent available) - Presence of active malignant disease

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Netherlands

Outcome results