Health status and burden of late effects in very long-term testicular cancer survivors.
- Conditions
- testicular cancertesticular germ cell tumour1003859710038430
- Registration Number
- NL-OMON47425
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 280
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 <70 years at time of inclusion
2. Signed informed consent;Additional inclusion criteria for CT-group:
3. Patients treated with cisplatin-based chemotherapy for TC good or intermediate IGCCCG prognosis.
4. Age at start of TC treatment <40 yrs.
5. At least 20 years after start of treatment for TC at time of inclusion.;Additional inclusion criteria for RT-group:
3. Patients treated with radiotherapy for TC stage I or II.
4. Age at start of TC treatment < 40 yrs.
5. At least 20 years after start of treatment for TC at time of inclusion.;Additional inclusion criteria for SU- group:
3. Patients treated with orchidectomy only for TC stage I.
4. Age at start of TC treatment < 40 yrs.
5. At least 20 years after start of treatment for TC at time of inclusion.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary study parameters are is renal function as expressed by glomerular<br /><br>filtration rate (GFR). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary parameters are the prevalence of the following defined adverse late<br /><br>effects: CVD, peripheral neuropathy, reduced lung function, Raynaud*s<br /><br>phenomenon, hypogonadism, fatigue and cognitive dysfunction. Other secondary<br /><br>parameters are health related quality of life (HRQoL), physical fitness,<br /><br>markers for (subclinical) vascular damage, single nucleotide polymorphisms<br /><br>(SNPs) and aging markers (telomere length in DNA and arterial stiffness).</p><br>