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

January 3, 2023 updated by: J.A. Gietema, University Medical Center Groningen
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Actual)

281

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glomerular filtration rate (GFR) in ml/min
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 years
Peripheral neuropathy (anamnestic with SCIN questionnaire which assesses a.o. chemotherapy-induced peripheral sensory neuropathy)
Time Frame: 3 years
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
3 years
Lung function (FEV1, FVC, TLC, RV, FRC and diffusion capacity (DLCO, KCO))
Time Frame: 3 years
3 years
Hypogonadism (LH > 10 U/l or testosterone < 14 ng/ml)
Time Frame: 3 years
3 years
Cognitive function (neuropsychological assessment of different domains: learning, memory, processing speed, executive function)
Time Frame: 3 years
3 years
Fatigue (scaled; VVV-questionnaire)
Time Frame: 3 years
3 years
Testicular cancer disease characteristics: stage, prognosis group, chemotherapy regimen/dose, radiotherapy doses/location
Time Frame: 3 years
3 years
Health-related quality of life (HRQoL)
Time Frame: 3 years
3 years
Physical fitness (according to six-minute walk test with sex, age and BMI specific reference values)
Time Frame: 3 years
3 years
Intima media thickness (IMT)
Time Frame: 3 years
3 years
Advanced Glycation End products (AGEs)
Time Frame: 3 years
3 years
Cardiovascular risk factors (presence of hypertension, dyslipidemia, impaired fasting glucose, overweight/obesity, tobacco and alcohol use, family history)
Time Frame: 3 years
3 years
Genetic susceptibility for (cardio)vascular damage (single nucleotide polymorphisms (SNPs) in DNA)
Time Frame: 3 years
3 years
Leukocyte telomere length
Time Frame: 3 years
3 years
Arterial stiffness measured as pulse-wave velocity (PWV)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Jourik Gietema, MD PhD, Universirty Medical Centre Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

January 10, 2020

Study Completion (Anticipated)

January 1, 2024

Study Registration Dates

First Submitted

August 27, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL53126.042.15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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