TACkLE Study - Tackling Adverse Chemotherapy-associated Late Effects

NCT02276430 | Active Not Recruiting

• 2 other identifiers: KWF2011-5209NL45655.042.13
• Study Type: observational
• Target: 939
• Locations: 1 country
• Sites: 3

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 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

Testicular Cancer

Keywords

Testicular cancer; Survivor; Cardiovascular disease; Risk factors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 years

Secondary Outcomes (8)

• Biomarkers for endothelial activation, hemostatic activity and inflammatory activity after TC treatment and relation with CVD

  4 years

• Hypogonadism after TC treatment and relation with CVD

  4 years

• DNA and telomere length analysis and association with (riskfactors for) CVD

  4 years

• Quality of life

  4 years

• Circulating platinum levels

  4 years

Study Arms (2)

Cases

Patients who developed cardiovascular disease after testicular cancer treatment

Other: Vena punction

Subcohort members

A random selection out of the total cohort of testicular cancer patients per participating hospital

Other: Vena punction

Interventions

Vena punction OTHER

Once 90 ml

Cases; Subcohort members

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Testicular cancer survivors

You may qualify if:

• Younger than 40 years of age at TC diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead
• The Netherlands Cancer Institute: collaborator

Study Sites (3)

Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center St. Radboud

Nijmegen, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 37071834 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples: analysis of cardiovascular risk factors (lipid profile, glucose metabolism, hormonal status), platinum levels and several biomarkers. Urine samples: microalbuminuria, platinum levels. DNA: polymorphisms in candidate genes for development of cardiovascular damage, leukocyte telomere length

MeSH Terms

Conditions

Testicular Neoplasms; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Study Officials

• J. A. Gietema, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: October 28, 2014
• Study Start: July 1, 2014
• Primary Completion: May 8, 2017
• Study Completion: April 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)