Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02572934 |
| Other study ID # |
NL53126.042.15 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 2015 |
| Est. completion date |
January 2025 |
Study information
| Verified date |
May 2024 |
| Source |
University Medical Center Groningen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
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.
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.
