This trial is active, not recruiting.

Condition former patients (survivors and deceased) with a diagnosis of cancer in childhood and adolescence between 1980-90 in germany.
Sponsor CVSS study
Collaborator Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology
Start date October 2013
End date February 2016
Trial size 1000 participants
Trial identifier NCT02181049, CVSS-study


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Heart failure
time frame: up to 35 years after exposure to childhood cancer therapy
time frame: up to 35 years after exposure to childhood cancer therapy

Secondary Outcomes

Myocardial infarction
time frame: up to 35 years after exposure to childhood cancer therapy
Late-occurring stroke
time frame: up to 35 years after exposure to childhood cancer therapy
Carotid artery disease
time frame: up to 35 years after exposure to childhood cancer therapy

Eligibility Criteria

Male or female participants from 24 years up to 49 years old.

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

Additional Information

Official title Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
Principal investigator Joerg Faber, Univ. Prof. Dr. med.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Johannes Gutenberg University Mainz.