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Clinical Trials/NCT02181049
NCT02181049
Active, not recruiting
Not Applicable

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

CVSS study1 site in 1 country1,000 target enrollmentOctober 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood and Adolescence Cancer (Survivors and Deceased)
Sponsor
CVSS study
Enrollment
1000
Locations
1
Primary Endpoint
Heart failure
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2013
End Date
October 2028
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
CVSS study
Responsible Party
Sponsor Investigator
Principal Investigator

CVSS study

interdisciplinary cooperation

Johannes Gutenberg University Mainz

Eligibility Criteria

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

Outcomes

Primary Outcomes

Heart failure

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

Hypertension

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

Secondary Outcomes

  • Myocardial infarction(up to 35 years after exposure to childhood cancer therapy)
  • Late-occurring stroke(up to 35 years after exposure to childhood cancer therapy)
  • Carotid artery disease(up to 35 years after exposure to childhood cancer therapy)

Study Sites (1)

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