Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS) (CVSS)

Cardiac and Vascular Late Sequelae in Long-term Survivors of Childhood Cancer (CVSS): a Multidisciplinary Clinical, Epidemiological and Genetic Approach

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Childhood and Adolescence Cancer (Survivors and Deceased)

• Study Type: Observational
• Enrollment (Actual): 1000

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • University Medical Center of the Johannes Gutenberg University Mainz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 49 years (Adult)
• Accepts Healthy Volunteers: N/A

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart failure	up to 35 years after exposure to childhood cancer therapy
Hypertension	up to 35 years after exposure to childhood cancer therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial infarction		up to 35 years after exposure to childhood cancer therapy
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
Carotid artery disease		up to 35 years after exposure to childhood cancer therapy

Collaborators and Investigators

• Sponsor: CVSS study
• Collaborators: 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; Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)
• Investigators: Principal Investigator: Joerg Faber, Univ.-Prof. Dr. med., Center for Pediatrics, Pediatric Hematology, Oncology and Hemostaseology, University Medical Center of the Johannes Gutenberg University Mainz; Principal Investigator: Philipp S Wild, Univ.-Prof. Dr. med. MSc, 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; Principal Investigator: Hiltrud Merzenich, Dr. oec. troph., Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): October 1, 2018
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: June 27, 2014
• First Submitted That Met QC Criteria: July 1, 2014
• First Posted (Estimated): July 3, 2014

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular; Cardiac; Vascular; Childhood cancer survivors; Late-sequelae
• Additional Relevant MeSH Terms: Pathologic Processes; Death
• Other Study ID Numbers: CVSS-study