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NCT Number: NCT02181049

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

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.

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Key information

Age range

24 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center of the Johannes Gutenberg University Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Survivors of oncological disease according to ICCC-3 aged <15 years at diagnosis, diagnosed 1980-1990 while resident in Germany
  • Declaration of consent for storage of personal data at GCCR

Exclusion criteria

  • Patient has refused contact with GCCR
  • Current address not available
  • Second malignant neoplasm
  • Diagnosis Morbus Hodgkin
  • Diagnosis WILMS tumor in 1990
  • Former treating center recommends exclusion
  • Insufficient knowledge of German language
  • Inability to travel to the study center and participate in the examinations

Treatment and study plan

Primary outcomes

  1. Heart failure

    Time frame: up to 35 years after exposure to childhood cancer therapy

  2. Hypertension

    Time frame: up to 35 years after exposure to childhood cancer therapy

Secondary outcomes

  1. Myocardial infarction

    Time frame: up to 35 years after exposure to childhood cancer therapy

  2. Late-occurring stroke

    Time frame: up to 35 years after exposure to childhood cancer therapy

    "late" is defined as 5 years or more after diagnosis of cancer

  3. Carotid artery disease

    Time frame: up to 35 years after exposure to childhood cancer therapy

Sponsors and collaborators

Lead sponsor

CVSS study

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: CVSS

Important dates

Study start
2013
Primary completion
2018
Study completion
2028
First posted
Jul 3, 2014
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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