Testicular CancerTACkLENCT02276430
TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects
An observational study of Testicular Cancer, run by University Medical Center Groningen at 3 sites in Netherlands.
Trial summary
Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years. Their life expectancy has greatly improved due to the introduction of platinum-containing chemotherapy for disseminated TC in the late 1970s. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Testicular Cancer
- What is being tested?
- Vena punction
- How many people
- 939 participants
- Where
- 3 sitesNetherlands
- Study dates
- Jul 2014to Apr 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Testicular cancer survivors
Who may be able to join
None listed.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Mental disorder (no informed consent available)
- Presence of active malignant disease
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Antoni van Leeuwenhoek Hospital
Amsterdam
University Medical Center Groningen
Groningen, 9700 RB
University Medical Center St. Radboud
Nijmegen
About this study
Official title: A Case-cohort Study to Identify Risk Factors for Cardiovascular Disease in Testicular Cancer Survivors
Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years. Their life expectancy has greatly improved due to the introduction of platinum-containing chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays, prevention or early detection of late adverse effects of TC treatment has become increasingly important. Current literature suggests that TC treatment, and specifically exposure to platinum agents, is associated with increased risk of cardiovascular morbidity and mortality. The precise role of treatment components like platinum in the pathogenesis of cardiometabolic changes and cardiovascular disease (CVD) warrants further investigation, since it is not known if CVD develops through direct platinum-induced damage of the vascular wall or by mediation through development of cardiometabolic riskfactors. The aim of this study is to identify risk factors for development for CVD after treatment for TC. A more profound insight into pathophysiologic mechanisms and identification of risk factors for CVDs is needed to facilitate development of preventive strategies and to optimize survivorship care.
Read the detailed description
Design: The investigators will perform a multicenter case-cohort study. Patients treated for TC who developed cardiac disease ((either myocardial infarction, proven coronary artery disease (grade ≥2) or congestive heart failure (grade ≥2)) will be invited by their (former) treating oncologist to participate in this study (cases). Furthermore, in each hospital a random sample of 15% of the total population treated for TC will be invited (the subcohort). The investigators will collect detailed diagnostic- and treatment data on TC and on (risk factors for) CVD for all cases as well as for all subcohort members. All cases and subcohort members will be approached to complete a questionnaire and to donate a blood sample for DNA analysis, after written informed consent. Patients who were younger than 40 years at TC diagnosis and younger than 75 years at moment of study contact will be asked to participate in the cardiometabolic risk inventory sub study. For this, participants have to undergo a basic study assessment consisting of physical examination, venapuncture and handing in a morning urine sample. This assessment can be performed at the participating hospital, their general practitioner or during a home visit by a member of the investigators research team. Additional (non-invasive) cardiovascular function measurements (IMT and AGEs) are only performed in the UMCG.
- Conditions
- Testicular Cancer
- Being tested
- Vena punction
- Keywords
- Testicular cancer, Survivor, Cardiovascular disease, Risk factors
- Medical subject headings
- Testicular Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vena punctionOther
Once 90 ml
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients who developed cardiovascular disease after testicular cancer treatment Receives: Other: Vena punction | |
| Subcohort members | A random selection out of the total cohort of testicular cancer patients per participating hospital Receives: Other: Vena punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characteristics of disease (i.e. stage/IGCCCG prognosis group) and treatment (chemotherapy/radiotherapy)
To evaluate the independent and joint effects of disease- and treatment characteristics of TC patients on cardiovascular disease risk.
Measured: 4 years
Cardiovascular risk factors
To evaluate the effect of cardiometabolic risk factors (presence of metabolic syndrome, smoking behaviour, obesity, hypertension, dyslipidemia, diabetes mellitus, family history, physical activity) on cardiovascular disease risk in TC patients.
Measured: 4 years
Secondary outcomes (8)
Biomarkers for endothelial activation, hemostatic activity and inflammatory activity after TC treatment and relation with CVD
To determine endothelial activation, hemostatic activity and inflammatory activity (represented by circulating biochemical markers) years after treatment for TC and its relationship between development of (components of) the metabolic syndrome and development of cardiovascular diseases.
Measured: 4 years
Hypogonadism after TC treatment and relation with CVD
To evaluate the presence of hypogonadism in TC survivors and to investigate the association between hypogonadism and presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
DNA and telomere length analysis and association with (riskfactors for) CVD
To investigate the presence of candidate single nucleotide polymorphisms in genomic DNA and telomere length and its association with presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
Quality of life
To investigate the impact of cardiovascular disease on Quality of Life (QoL) in TC survivors.
Measured: 4 years
Circulating platinum levels
In patients treated with platinum-containing chemotherapy: to evaluate circulating platinum levels in TC survivors and to investigate the relationship between circulating platinum levels and presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
Intima media thickness
Patients visiting the UMCG for the study visit: to evaluate thickness of the intima media of the carotid artery as a marker for subclinical damage in TC survivors, and to investigate the relationship between abnormal intima media thickness and presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
Arterial stiffness
Patients visiting the UMCG for the study visit: to assess the elasticity of the arterial wall of the carotid artery in TC survivors, and to investigate the relationship between abnormal arterial stiffness and presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
Skin auto fluorescence (SAF) as measure for Advanced Glycation End products (AGEs)
Patients visiting the UMCG for the study visit: to assess levels of AGEs with help of the SAF in TC survivors and to to investigate the relationship between SAF and presence of (components of) the metabolic syndrome and development of cardiovascular disease.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startJul 2014
- Primary completion8 May 2017
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Testicular CancerStudies of the same condition, open and under way.
- 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
- 939 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Responsible party
- Sponsor
- Investigators
- J. A. Gietema, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02276430
- Sponsor's protocol ID
- KWF2011-5209
- Other IDs
- NL45655.042.13
- Acronym
- TACkLE
- Status last verified
- Sep 2025
- First submitted
- 31 Jul 2014
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lubberts S, Groot HJ, de Wit R, Mulder S, Witjes JA, Kerst JM, Groenewegen G, Lefrandt JD, van Leeuwen FE, Nuver J, Schaapveld M, Gietema JA. Cardiovascular Disease in Testicular Cancer Survivors: Identification of Risk Factors and Impact on Quality of Life. J Clin Oncol. 2023 Jul 1;41(19):3512-3522. doi: 10.1200/JCO.22.01016. Epub 2023 Apr 18.
PubMed 37071834
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case-cohort Study to Identify Risk Factors for Cardiovascular Disease in Testicular Cancer Survivors
- ClinicalTrials.gov ID
- NCT02276430
- Acronym / sponsor ID
- TACkLE / KWF2011-5209
- Conditions
- Testicular Cancer
- Keywords
- Testicular cancer, Survivor, Cardiovascular disease, Risk factors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 939 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- The Netherlands Cancer Institute
- Study start
- Jul 2014
- Primary completion
- 8 May 2017 (actual)
- Study completion
- Apr 2026 (estimated)
- First posted
- 28 Oct 2014 (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.
Testicular cancer (TC) is a rare disease, which mostly affects young men aged 15-35 years. Their life expectancy has greatly improved due to the introduction of platinum-containing chemotherapy for disseminated TC in the late 1970s. Given the good prognosis of TC nowadays, prevention or early detection of late adverse effects of TC treatment has become increasingly important. Current literature suggests that TC treatment, and specifically exposure to platinum agents, is associated with increased risk of cardiovascular morbidity and mortality. The precise role of treatment components like platinum in the pathogenesis of cardiometabolic changes and cardiovascular disease (CVD) warrants further investigation, since it is not known if CVD develops through direct platinum-induced damage of the vascular wall or by mediation through development of cardiometabolic riskfactors. The aim of this study is to identify risk factors for development for CVD after treatment for TC. A more profound insight into pathophysiologic mechanisms and identification of risk factors for CVDs is needed to facilitate development of preventive strategies and to optimize survivorship care.
Detailed description
Design: The investigators will perform a multicenter case-cohort study. Patients treated for TC who developed cardiac disease ((either myocardial infarction, proven coronary artery disease (grade ≥2) or congestive heart failure (grade ≥2)) will be invited by their (former) treating oncologist to participate in this study (cases). Furthermore, in each hospital a random sample of 15% of the total population treated for TC will be invited (the subcohort). The investigators will collect detailed diagnostic- and treatment data on TC and on (risk factors for) CVD for all cases as well as for all subcohort members. All cases and subcohort members will be approached to complete a questionnaire and to donate a blood sample for DNA analysis, after written informed consent. Patients who were younger than 40 years at TC diagnosis and younger than 75 years at moment of study contact will be asked to participate in the cardiometabolic risk inventory sub study. For this, participants have to undergo a basic study assessment consisting of physical examination, venapuncture and handing in a morning urine sample. This assessment can be performed at the participating hospital, their general practitioner or during a home visit by a member of the investigators research team. Additional (non-invasive) cardiovascular function measurements (IMT and AGEs) are only performed in the UMCG.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Vena punctionPatients who developed cardiovascular disease after testicular cancer treatment |
| Subcohort members | – | Other: Vena punctionA random selection out of the total cohort of testicular cancer patients per participating hospital |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Testicular cancer survivors
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Mental disorder (no informed consent available)
- Presence of active malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vena punctionOnce 90 ml | Other | Cases, Subcohort members |
Primary outcome
Characteristics of disease (i.e. stage/IGCCCG prognosis group) and treatment (chemotherapy/radiotherapy)
Time frame: 4 years
To evaluate the independent and joint effects of disease- and treatment characteristics of TC patients on cardiovascular disease risk.
Cardiovascular risk factors
Time frame: 4 years
To evaluate the effect of cardiometabolic risk factors (presence of metabolic syndrome, smoking behaviour, obesity, hypertension, dyslipidemia, diabetes mellitus, family history, physical activity) on cardiovascular disease risk in TC patients.
8 secondary outcomes
Biomarkers for endothelial activation, hemostatic activity and inflammatory activity after TC treatment and relation with CVD
Time frame: 4 years
Hypogonadism after TC treatment and relation with CVD
Time frame: 4 years
DNA and telomere length analysis and association with (riskfactors for) CVD
Time frame: 4 years
Quality of life
Time frame: 4 years
Circulating platinum levels
Time frame: 4 years
Intima media thickness
Time frame: 4 years
Arterial stiffness
Time frame: 4 years
Skin auto fluorescence (SAF) as measure for Advanced Glycation End products (AGEs)
Time frame: 4 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 15 Sep 2025.
- Derived from this study: PubMed 37071834Lubberts S, Groot HJ, de Wit R, Mulder S, Witjes JA, Kerst JM, Groenewegen G, Lefrandt JD, van Leeuwen FE, Nuver J, Schaapveld M, Gietema JA. Cardiovascular Disease in Testicular Cancer Survivors: Identification of Risk Factors and Impact on Quality of Life. J Clin Oncol. 2023 Jul 1;41(19):3512-3522. doi: 10.1200/JCO.22.01016. Epub 2023 Apr 18.
- 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.
J. A. Gietema, MD, PhD principal investigator
University Medical Center Groningen
3 sites 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 3 sites 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 0 inclusion and 3 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Characteristics of disease (i.e. stage/IGCCCG prognosis group) and treatment (chemotherapy/radiotherapy) (time frame: 4 years). The study lists 2 primary outcomes in all. 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 NCT02276430, which also lists 1 linked publication.
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 15 Sep 2025; AzTrials last refreshed its copy on 31 Oct 2026.