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

NCT02181049 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2024-03-06

No results posted yet for this study

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.

Conditions

  • Childhood and Adolescence Cancer (Survivors and Deceased)

Sponsors & Collaborators

  • Univ. Prof. Dr. med. Joerg Faber, Center for Pediatrics, Hematology, Oncology and Hemostaseology

    collaborator UNKNOWN
  • Univ. Prof. Dr. med. Philipp S. Wild, MSc, Preventive Cardiology and Preventive Medicine, Center for Cardiology, Clinical Epidemiology, CTH

    collaborator UNKNOWN
  • Dr. oec. troph. Hiltrud Merzenich, Insitute for Medical Biometry, Epidemiology and Informatics (IMBEI)

    collaborator UNKNOWN
  • CVSS study

    lead OTHER

Principal Investigators

  • Joerg Faber, Univ.-Prof. Dr. med. · Center for Pediatrics, Pediatric Hematology, Oncology and Hemostaseology, University Medical Center of the Johannes Gutenberg University Mainz

  • 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

  • Hiltrud Merzenich, Dr. oec. troph. · Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center of the Johannes Gutenberg University Mainz

Eligibility

Min Age
24 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2018-10-31
Completion
2028-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181049 on ClinicalTrials.gov