Status:
ACTIVE_NOT_RECRUITING
TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
The Netherlands Cancer Institute
Conditions:
Testicular Cancer
Eligibility:
MALE
18-75 years
Brief 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 di...
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) ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
939 Patients enrolled
Trial Details
Trial ID
NCT02276430
Start Date
July 1 2014
End Date
April 1 2026
Last Update
September 15 2025
Active Locations (3)
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1
Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands
2
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
3
University Medical Center St. Radboud
Nijmegen, Netherlands