Testicular CancerSTANDBYNCT02572934
Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)
An observational study of Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Testicular Cancer
- How many people
- 281 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2015to Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Potential participating TC survivors will be identified by the TC registry of the uro-oncology tumor working group of the UMCG. The investigators will randomly select (with an SPSS-query) 70 potential participants from the CT-group and search for age-matched controls in the RT-, SU- and CO-group. A margin of three years will be accepted. If no matching RT-patients, SU-patients or healthy volunteers are available, age-matching criteria will be relaxed by allowing the difference to increase with one year at each step, to a maximum of six years. Vital status will be checked with help of information from the municipal population registry (GBA:'gemeentelijke basisadministratie'). Healthy volunteers are recruited via advertisements in local door-to-door papers and by flyers exposed in the UMCG.
Who may be able to join
- Age <70 years at time of inclusion
- Signed informed consent
- CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
- CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
- CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
- RT-group: Patients treated with radiotherapy for TC stage I or II.
- SU-group: Patients treated with orchidectomy only for TC stage I.
Who cannot join
- Mental disorder (no informed consent available).
- CT-group: Patients also treated with radiotherapy for TC.
- RT-group: Patients also treated with chemotherapy for TC.
- SU-group: Patients also treated with chemo- or radiotherapy for TC.
- CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objective: The aim of this study is to compare glomerular filtration rate (GFR) in very long-term testicular cancer (TC)-survivors treated with chemotherapy, radiotherapy or surgery only and non-cancer treated healthy controls. Secondary aim is to assess prevalence of adverse late treatment effects in very long-term TC-survivors treated with chemotherapy (CT), radiotherapy (RT) or surgery only (SU) and investigate the relationship between GFR parameters and these late effects.
Study population: Patients treated with CT, RT or only surgery for TC more than 20 years ago and an age-matched male control population.
Study design: An observational cross-sectional cohort study will be performed. Patients will be invited for a single study visit, which consists of collection of urine during 24 hours, withdrawal of blood samples, filling in questionnaires, physical examination, vascular function and structure tests, lung function tests, digital cooling tests, neuropsychological assessment and a walk test.
Main study parameters/endpoints: Primary study parameter is renal function as expressed by glomerular filtration rate (GFR). Secondary endpoints are the prevalence of the following defined adverse late effects: cardiovascular disease (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.
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer, Survivorship, late adverse treatment effects
- Medical subject headings
- Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy group (CT-group) | Patients treated with chemotherapy >20 years ago | |
| Radiotherapy group (RT-group) | Patients treated with radiotherapy >20 years ago | |
| Surgery-only group (SU-group) | Patients treated with only orchidectomy >20 years ago | |
| Control-group | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate (GFR) in ml/min
Measured: 3 years
Secondary outcomes (16)
Development of cardiovascular disease (CVD) according to the WHO ICD-10 classification (I10-I15: hypertensive disease; I20-I25: ischemic heart disease; I60-I69: cerebrovascular disease; I70-I79: disease of arteries, arterioles and capillaries)
Measured: 3 years
Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)
Measured: 3 years
Raynaud's phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud's phenomenon and objectified with standardized digital cooling tests)
Measured: 3 years
Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))
Measured: 3 years
Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)
Measured: 3 years
Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function)
Measured: 3 years
Fatigue (scaled; VVV-questionnaire)
Measured: 3 years
Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location
Measured: 3 years
Health-related quality of life (HRQoL)
Measured: 3 years
Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values)
Measured: 3 years
Intima media thickness (IMT)
Measured: 3 years
Advanced Glycation End products (AGEs)
Measured: 3 years
Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history)
Measured: 3 years
Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA)
Measured: 3 years
Leukocyte telomere length
Measured: 3 years
Arterial stiffness measured as pulse-wave velocity (PWV)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startAug 2015
- Primary completion10 Jan 2020
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jourik Gietema, MD PhD, Principal investigator, Universirty Medical Centre Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572934
- Sponsor's protocol ID
- NL53126.042.15
- Acronym
- STANDBY
- Status last verified
- May 2025
- First submitted
- 27 Aug 2015
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stelwagen 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.
PubMed 34830829Stelwagen 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.
PubMed 32921790
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)
- ClinicalTrials.gov ID
- NCT02572934
- Acronym / sponsor ID
- STANDBY / NL53126.042.15
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer, Survivorship, late adverse treatment effects
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 281 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- Jan 2026 (estimated)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: The aim of this study is to compare glomerular filtration rate (GFR) in very long-term testicular cancer (TC)-survivors treated with chemotherapy, radiotherapy or surgery only and non-cancer treated healthy controls. Secondary aim is to assess prevalence of adverse late treatment effects in very long-term TC-survivors treated with chemotherapy (CT), radiotherapy (RT) or surgery only (SU) and investigate the relationship between GFR parameters and these late effects.
Study population: Patients treated with CT, RT or only surgery for TC more than 20 years ago and an age-matched male control population.
Study design: An observational cross-sectional cohort study will be performed. Patients will be invited for a single study visit, which consists of collection of urine during 24 hours, withdrawal of blood samples, filling in questionnaires, physical examination, vascular function and structure tests, lung function tests, digital cooling tests, neuropsychological assessment and a walk test.
Main study parameters/endpoints: Primary study parameter is renal function as expressed by glomerular filtration rate (GFR). Secondary endpoints are the prevalence of the following defined adverse late effects: cardiovascular disease (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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy group (CT-group) | – | –Patients treated with chemotherapy >20 years ago |
| Radiotherapy group (RT-group) | – | –Patients treated with radiotherapy >20 years ago |
| Surgery-only group (SU-group) | – | –Patients treated with only orchidectomy >20 years ago |
| Control-group | – | –Healthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Potential participating TC survivors will be identified by the TC registry of the uro-oncology tumor working group of the UMCG. The investigators will randomly select (with an SPSS-query) 70 potential participants from the CT-group and search for age-matched controls in the RT-, SU- and CO-group. A margin of three years will be accepted. If no matching RT-patients, SU-patients or healthy volunteers are available, age-matching criteria will be relaxed by allowing the difference to increase with one year at each step, to a maximum of six years. Vital status will be checked with help of information from the municipal population registry (GBA:'gemeentelijke basisadministratie'). Healthy volunteers are recruited via advertisements in local door-to-door papers and by flyers exposed in the UMCG.
Key inclusion criteria (7 listed)
- Age <70 years at time of inclusion
- Signed informed consent
- CT-, RT- and SU-group: Age at start of TC treatment <40 yrs.
- CT-, RT- and SU-group: At least 20 years after start of treatment for TC at time of inclusion.
- CT-group: Patients treated with cisplatin-based chemotherapy for TC with good or intermediate prognosis (according to IGCCCG prognosis group).
Key exclusion criteria (5 listed)
- Mental disorder (no informed consent available).
- CT-group: Patients also treated with radiotherapy for TC.
- RT-group: Patients also treated with chemotherapy for TC.
- SU-group: Patients also treated with chemo- or radiotherapy for TC.
- CO-group: Treated with chemotherapy, radiotherapy or hormonal therapy for any type of cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glomerular filtration rate (GFR) in ml/min
Time frame: 3 years
16 secondary outcomes
Development of cardiovascular disease (CVD) according to the WHO ICD-10 classification (I10-I15: hypertensive disease; I20-I25: ischemic heart disease; I60-I69: cerebrovascular disease; I70-I79: disease of arteries, arterioles and capillaries)
Time frame: 3 years
Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)
Time frame: 3 years
Raynaud's phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud's phenomenon and objectified with standardized digital cooling tests)
Time frame: 3 years
Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))
Time frame: 3 years
Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)
Time frame: 3 years
Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function)
Time frame: 3 years
Fatigue (scaled; VVV-questionnaire)
Time frame: 3 years
Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location
Time frame: 3 years
Health-related quality of life (HRQoL)
Time frame: 3 years
Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values)
Time frame: 3 years
Intima media thickness (IMT)
Time frame: 3 years
Advanced Glycation End products (AGEs)
Time frame: 3 years
Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history)
Time frame: 3 years
Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA)
Time frame: 3 years
Leukocyte telomere length
Time frame: 3 years
Arterial stiffness measured as pulse-wave velocity (PWV)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 34830829Stelwagen 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.
- Derived from this study: PubMed 32921790Stelwagen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jourik Gietema, MD PhD principal investigator
Universirty Medical Centre Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testicular Cancer, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (GFR) in ml/min (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572934, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.