Clinical trial NCT02181049: Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS)
Official title: Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Childhood and Adolescence Cancer (Survivors and Deceased)
Keywords: Childhood cancer survivors
Cardiac
Vascular
Cardiovascular
Late-sequelae
Lead sponsor: Johannes Gutenberg University Mainz
Sponsor class: OTHER
Collaborators: name: Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology
name: Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH
name: Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)
First posted: 2014-07-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 24
Maximum age (years): 49
Standard ages: ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Survivors of a oncological disease according to ICCC-3 aged \<15 years at diagnosis, diagnosed 1980-1990 while resident in Germany

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.


Eligibility criteria: 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

Primary outcomes:
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:
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
measure: Carotid artery disease
timeFrame: up to 35 years after exposure to childhood cancer therapy
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: University Medical Center of the Johannes Gutenberg University Mainz
state: Rhineland-Palatinate
Study officials:
affiliation: Center for Pediatrics, Pediatric Hematology, Oncology and Hemostaseology, University Medical Center of the Johannes Gutenberg University Mainz
name: Joerg Faber, Univ.-Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, Center for Thrombosis and Hemostasis (CTH), University Medical Center of the Johannes Gutenberg University Mainz
name: Philipp S Wild, Univ.-Prof. Dr. med. MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz
name: Hiltrud Merzenich, Dr. oec. troph.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold 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.