MedPath

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

Completed
Conditions
testicular cancer
testicular germ cell tumour
10038597
10038430
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
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 <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

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
NameTimeMethod
<p>Primary study parameters are is renal function as expressed by glomerular<br /><br>filtration rate (GFR). </p><br>
Secondary Outcome Measures
NameTimeMethod
<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>
© Copyright 2025. All Rights Reserved by MedPath