Clinical trial · Observational
Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS)
Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
- 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)
Due to remarkable advances in childhood cancer therapy the 10-year survival rate increased to over 80% and late sequelae come to the fore. Childhood cancer survivors (CCS) suffer from significant excess in mortality risk associated with treatment-related complications at least for 25 years after the initial cancer diagnosis. In particular, the prevalence of cardiovascular disease seems to be elevated compared to the general population. The CVSS study is a multi-disciplinary cooperation project between the Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI) and the German Childhood Cancer Registry (GCCR), the Preventive Cardiology and Preventive Medicine and the Pediatric Hematology and Oncology all at the University Medical Center of the Johannes Gutenberg University Mainz. The central element is a thorough clinical cardiovascular examination of all patients, which permits detecting subclinical disease. Therapy data will be extracted retrospectively from various sources. The study intends to describe the current situation of a cohort of approximately 1000 CCS in Germany aged 24 to 49 years with respect to cardiovascular health. The role of risk factors (treatment related and classic cardiovascular risk factors), as well as related predisposing genetic factors is investigated. The results will contribute to recommendations to improve follow-up 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 |
|---|---|---|---|
| Childhood and Adolescence Cancer (Survivors and Deceased) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Heart failure
- timeFrame
- up to 35 years after exposure to childhood cancer therapy
- measure
- Hypertension
- timeFrame
- up to 35 years after exposure to childhood cancer therapy
Secondary outcomes (3)
- measure
- Myocardial infarction
- timeFrame
- up to 35 years after exposure to childhood cancer therapy
- measure
- Late-occurring stroke
- timeFrame
- up to 35 years after exposure to childhood cancer therapy
- description
- "late" is defined as 5 years or more after diagnosis of cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 24 Years
- Maximum age
- 49 Years
Show eligibility criteria text
Inclusion Criteria: 1. Survivors of oncological disease according to ICCC-3 aged \<15 years at diagnosis, diagnosed 1980-1990 while resident in Germany 2. Declaration of consent for storage of personal data at GCCR Exclusion Criteria: 1. Patient has refused contact with GCCR 2. Current address not available 3. Second malignant neoplasm 4. Diagnosis Morbus Hodgkin 5. Diagnosis WILMS tumor in 1990 6. Former treating center recommends exclusion 7. Insufficient knowledge of German language 8. Inability to travel to the study center and participate in the examinations
References
Publications (1)
- DERIVEDArnold N, Merzenich H, Wingerter A, Schulz A, Schneider A, Prochaska JH, Gobel S, Neu MA, Henninger N, Panova-Noeva M, Eckerle S, Spix C, Schmidtmann I, Lackner KJ, Beutel ME, Pfeiffer N, Munzel T, Faber J, Wild PS. Promotion of Arterial Stiffness by Childhood Cancer and Its Characteristics in Adult Long-Term Survivors. J Am Heart Assoc. 2021 Feb;10(5):e015609. doi: 10.1161/JAHA.119.015609. Epub 2021 Feb 24. PMID 33624513