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

Active, not recruiting

• Conditions: Childhood and Adolescence Cancer (Survivors and Deceased)

• Registration Number: NCT02181049
• Lead Sponsor: CVSS study

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-06-27
• Study First Submitted QC: 2014-07-01
• Study First Posted: 2014-07-03
• Primary Completion: 2018-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Study Completion: 2028-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	"late" is defined as 5 years or more after diagnosis of cancer
Carotid artery disease	up to 35 years after exposure to childhood cancer therapy

Trial Locations

Locations (1)

University Medical Center of the Johannes Gutenberg University Mainz; 🇩🇪 Mainz, Rhineland-Palatinate, Germany