Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT02572934
Study type Observational
Source University Medical Center Groningen
Contact
Status Active, not recruiting
Phase
Start date August 2015
Completion date January 2025

See also
  Status Clinical Trial Phase
Recruiting NCT00772694 - Sorafenib Monotherapy in Inoperable/Recurrent Germ Cell Carcinoma Refractory to Chemotherapy Phase 2
Completed NCT00705094 - Cardiac Function and Cardiovascular Risk Profile in Testicular Cancer Patients N/A
Terminated NCT00531687 - Trial of Paclitaxel, Gemcitabine and Cisplatin in Patients With Relapsing Germ Cell Cancer Phase 2
Terminated NCT00820287 - Identification of Predictive Markers for Testis Cancer in a Population of Men With High Risk N/A
Completed NCT00216801 - Relationship of Ochratoxin A to Upper Urologic Cancers N/A
Active, not recruiting NCT03142802 - Low-Dose CT - Stage I Testicular Cancer N/A
Recruiting NCT03232541 - The Effects of Acupuncture and the Therapist´s Communication on Chemotherapy Induced Nausea and Vomiting N/A
Completed NCT03557177 - Clinical Characterisation of the Vascular Effects of Cis-platinum Based Chemotherapy in Patients With Testicular Cancer
Active, not recruiting NCT01783145 - Shared Care Follow-up After Chemotherapy for Testicular Cancer
Recruiting NCT05611307 - Late Subclinical Cardiovascular Disease in Testicular Cancer Survivors
Completed NCT02573584 - Vascular Fingerprint Validation Study
Recruiting NCT05670938 - Follow-up After Surgery for Testicular Cancer
Recruiting NCT02994758 - Development of Diagnostics and Treatment of Urological Cancers N/A
Completed NCT02991209 - Study of Testosterone vs Placebo in Testicular Cancer Survivors Phase 2/Phase 3
Completed NCT02602041 - Knowledge and Attitudes Regarding Healthy Lifestyle and Health Behavior Change in Cancer Patients and Their Partners; A Pilot Study
Completed NCT02092740 - REtrospective Study of TESTIcular CAncer Patients at the University Magdeburg N/A
Completed NCT01482741 - Understanding Patient Perspectives on the Risks of Ionizing Radiation Used for Medical Imaging N/A
Active, not recruiting NCT01242072 - Intravenous Palifosfamide-tris in Combination With Etoposide and Carboplatin in Patients With Malignancies Phase 1
Completed NCT01242631 - Everolimus for Patients With Relapsed/Refractory Germ Cell Cancer Phase 2
Completed NCT01135849 - B-Receptor Signaling in Cardiomyopathy N/A