Childhood and Adolescence Cancer (Survivors and Deceased) Clinical Trial
— CVSSOfficial title:
Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
| Verified date | March 2024 |
| Source | Johannes Gutenberg University Mainz |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Active, not recruiting |
| Enrollment | 1000 |
| Est. completion date | October 2028 |
| Est. primary completion date | October 2018 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 24 Years to 49 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Germany | University Medical Center of the Johannes Gutenberg University Mainz | Mainz | Rhineland-Palatinate |
| Lead Sponsor | Collaborator |
|---|---|
| CVSS study | Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI), Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology, Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Heart failure | up to 35 years after exposure to childhood cancer therapy | ||
| Primary | Hypertension | up to 35 years after exposure to childhood cancer therapy | ||
| Secondary | Myocardial infarction | up to 35 years after exposure to childhood cancer therapy | ||
| Secondary | Late-occurring stroke | "late" is defined as 5 years or more after diagnosis of cancer | up to 35 years after exposure to childhood cancer therapy | |
| Secondary | Carotid artery disease | up to 35 years after exposure to childhood cancer therapy |