Health status and burden of late effects in very long-term testicular cancer survivors.

Health status and burden of late effects in very long-term testicular cancer survivors. - STANDBY-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47425

Enrollment

280

Registered

2015-08-06

Start date

2015-08-19

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

testicular cancer testicular germ cell tumour

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Three groups of TC survivors will be included: treated with surgery and chemotherapy (CT group), surgery and radiotherapy (RT group) or surgery only (SU group). We also will include a control group (CO group) of healthy volunteers who have not been treated for any type of cancer. The groups will be age matched with te patients from the CT group, a margin of three years will be accepted.;Inclusion criteria for both TC survivors as controls: 1. Age

Exclusion criteria

Exclusion criteria: Exclusion criteria for both TC survivors as controls: 1. Mental disability (no informed consent available).;Additional exclusion criteria for CT-group: 2. Patients also treated with radiotherapy for TC.;Additional exclusion criteria for RT-group: 2. Patients also treated with chemotherapy for TC.;Additional exclusion criteria for SU-group: 2. Patients also treated with chemo- or radiotherapy for TC.;Additional exclusion criteria for CO-group: 2. Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.

Design outcomes

Primary

Measure	Time frame
Primary study parameters are is renal function as expressed by glomerular filtration rate (GFR).	—

Secondary

Measure	Time frame
Secondary parameters are the prevalence of the following defined adverse late effects: CVD, peripheral neuropathy, reduced lung function, Raynaud*s phenomenon, hypogonadism, fatigue and cognitive dysfunction. Other secondary parameters are health related quality of life (HRQoL), physical fitness, markers for (subclinical) vascular damage, single nucleotide polymorphisms (SNPs) and aging markers (telomere length in DNA and arterial stiffness).	—

Measure

Time frame

Secondary parameters are the prevalence of the following defined adverse late effects: CVD, peripheral neuropathy, reduced lung function, Raynaud*s phenomenon, hypogonadism, fatigue and cognitive dysfunction. Other secondary parameters are health related quality of life (HRQoL), physical fitness, markers for (subclinical) vascular damage, single nucleotide polymorphisms (SNPs) and aging markers (telomere length in DNA and arterial stiffness).

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Countries

Netherlands

Outcome results