Health Status and Burden of Late Effects in Very Long-term Testicular Cancer Survivors (STANDBY-study)

NCT02572934 | Active Not Recruiting

• 1 other identifier: NL53126.042.15
• Study Type: observational
• Target: 281
• Locations: 1 country
• Sites: 1

Brief 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. 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

Testicular Cancer

Keywords

Testicular cancer; Survivorship; late adverse treatment effects

Outcome Measures

Primary Outcomes (1)

• Glomerular filtration rate (GFR) in ml/min

  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)

  3 years

• Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)

  3 years

• Raynaud's phenomenon (anamnestic with SCIN questionnaire which assesses a.o. Raynaud's phenomenon and objectified with standardized digital cooling tests)

  3 years

• Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))

  3 years

• Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)

  3 years

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Signed informed consent
• CT-, RT- and SU-group: Age at start of TC treatment \<40 yrs.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 34830829 DERIVED

• Stelwagen 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 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• Jourik Gietema, MD PhD

  Universirty Medical Centre Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: October 9, 2015
• Study Start: August 1, 2015
• Primary Completion: January 10, 2020
• Study Completion: January 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)