Clinical trial · Observational
Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Depending on disease stage, testicular cancer (TC) treatment consists of an orchidectomy, alone or followed by radiotherapy (RT) or platinum-based chemotherapy (CT). TC survival rates are above 90% nowadays, which results in growing TC survivor population. Because of the long life expectancy of these survivors, prevention or early detection of late treatment effects has become increasingly relevant. Yet known late effects are nephrotoxicity, cardiovascular disease (CVD), secondary malignant neoplasms (SMN), neurotoxicity, pulmonary toxicity, Raynaud's phenomenon, hypogonadism, fatigue and psychosocial problems. Nephrotoxicity is an important late effect, but data is lacking in very long-term survivors since performed studies have a follow-up duration of 5-14 years. Decreased renal function is a known risk factor for CVD development and also an association between renal function and neurtoxicity via circulating platinum levels has been shown. It is hypothesized that treatment induced nephrotoxicity is prevalent in TC survivors and might be a mediator for development of late effects. The secondary aim is to assess prevalence of late effects in very long-term TC survivors: until now, most data have been collected through questionnaires in large epidemiological studies in TC survivors till approximately 10 years after treatment. The prevalence of late effects may increase over time: 10 years after treatment late effects may not be present yet, whilst late effects can emerge just after 20 years. Consequently, health status and possible late effects, resulting in morbidity, are underestimated in patients who are 20-30 years after treatment. By investigating health status of these very long-term survivors a more profound insight in the prevalence and aetiology of these late effects and the development over time can be assessed. Current treatment is very similar to TC treatment 20-30 years ago and therefore knowledge on late effects is relevant for currently treated patients. Furthermore, as a result of this study, we will better understand which factors and issues should be watched closely during follow-up, which TC survivors are at increased risk of developing late treatment effects and how to detect early damage before overt morbidity occurs.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- Chemotherapy group (CT-group)
- description
- Patients treated with chemotherapy \>20 years ago
- label
- Radiotherapy group (RT-group)
- description
- Patients treated with radiotherapy \>20 years ago
- label
- Surgery-only group (SU-group)
- description
- Patients treated with only orchidectomy \>20 years ago
- label
- Control-group
- description
- Healthy controls
Primary outcomes (1)
- measure
- Glomerular filtration rate (GFR) in ml/min
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \<70 years at time of inclusion 2. Signed informed consent 3. CT-, RT- and SU-group: Age at start of TC treatment \<40 yrs. 4. CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion. 5. CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group). 6. RT-group: Patients treated with radiotherapy for TC stage I or II. 7. SU-group: Patients treated with orchidectomy only for TC stage I. Exclusion Criteria: 1. Mental disorder (no informed consent available). 2. CT-group: Patients also treated with radiotherapy for TC. 3. RT-group: Patients also treated with chemotherapy for TC. 4. SU-group: Patients also treated with chemo- or radiotherapy for TC. 5. CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.
References
Publications (2)
- DERIVEDStelwagen J, Meuleman AT, Lubberts S, Steursma G, Kruyt LM, Donkerbroek JW, Meijer C, Walenkamp AME, Lefrandt JD, Rakers SE, Huitema RB, de Jong MAA, Wiegman EM, van den Bergh ACM, de Jong IJ, van Rentergem JAA, Schagen SB, Nuver J, Gietema JA. Cognitive Impairment in Long-Term Survivors of Testicular Cancer More Than 20 Years after Treatment. Cancers (Basel). 2021 Nov 12;13(22):5675. doi: 10.3390/cancers13225675. PMID 34830829
- DERIVEDStelwagen J, Lubberts S, Steggink LC, Steursma G, Kruyt LM, Donkerbroek JW, van Roon AM, van Gessel AI, van de Zande SC, Meijer C, Grafin Zu Eulenburg CH, Oosting SF, Nuver J, Walenkamp AME, Jan de Jong I, Lefrandt JD, Gietema JA. Vascular aging in long-term survivors of testicular cancer more than 20 years after treatment with cisplatin-based chemotherapy. Br J Cancer. 2020 Nov;123(11):1599-1607. doi: 10.1038/s41416-020-01049-3. Epub 2020 Sep 14. PMID 32921790