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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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02181049
Acronym
CVSS
Enrollment
1000
Registered
2014-07-03
Start date
2013-10-31
Completion date
2028-10-31
Last updated
2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood and Adolescence Cancer (Survivors and Deceased)

Keywords

Childhood cancer survivors, Cardiac, Vascular, Cardiovascular, Late-sequelae

Brief summary

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.

Interventions

None listed

Sponsors

Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology
CollaboratorUNKNOWN
Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH
CollaboratorUNKNOWN
Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)
CollaboratorUNKNOWN
CVSS study
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
24 Years to 49 Years

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

Design outcomes

Primary

MeasureTime frame
Heart failureup to 35 years after exposure to childhood cancer therapy
Hypertensionup to 35 years after exposure to childhood cancer therapy

Secondary

MeasureTime frameDescription
Myocardial infarctionup to 35 years after exposure to childhood cancer therapy
Late-occurring strokeup to 35 years after exposure to childhood cancer therapylate is defined as 5 years or more after diagnosis of cancer
Carotid artery diseaseup to 35 years after exposure to childhood cancer therapy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026