Clinical trial · Observational
TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects
A Case-cohort Study to Identify Risk Factors for Cardiovascular Disease in Testicular Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vena punction | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cases
- description
- Patients who developed cardiovascular disease after testicular cancer treatment
- interventionNames
- Other: Vena punction
- label
- Subcohort members
- description
- A random selection out of the total cohort of testicular cancer patients per participating hospital
- interventionNames
- Other: Vena punction
Primary outcomes (2)
- measure
- Characteristics of disease (i.e. stage/IGCCCG prognosis group) and treatment (chemotherapy/radiotherapy)
- timeFrame
- 4 years
- description
- To evaluate the independent and joint effects of disease- and treatment characteristics of TC patients on cardiovascular disease risk.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
All participating patients have to meet the following criteria: * Alive * TC diagnosis between 01-01-1976 to 31-12-2007 * TC treatment center: UMCG, NKI/AVL, Erasmus MC, UMCN, LUMC * Younger than 50 years of age at TC diagnosis * Written informed consent Cases have to fulfill, beside the aforementioned criteria, the following criteria: * Diagnosed with either myocardial infarction (MI), proven coronary artery disease (CAD) (CTCAE-4 grade 2 or higher) or congestive heart failure (CHF) (CTCAE-4 grade 2 or higher). * No medical history of CVD before diagnosis of TC In order to be eligible to participate in the cardiometabolic risk inventory study (and to be invited to a study assessment), a subject must meet, next to the criteria mentioned in "1)", the following inclusion criteria: * Younger than 40 years of age at TC diagnosis * Younger than 75 years of age at moment of inclusion Exclusion criteria: 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
References
Publications (1)
- DERIVEDLubberts 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. PMID 37071834