Pharmacogenetic sub-study within the research project „Structure Optimization for Children with Cancer after Therapy with Anthracyclines (LESS-Anthra)
- Conditions
- MedDRA - 10048610: CardiotoxicityC74C64Malignant neoplasm of adrenal glandMalignant neoplasm of kidney, except renal pelvis
- Registration Number
- DRKS00015084
- Lead Sponsor
- Studienleiter des Late Effects Surveillance System (LESS)Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
Patients are invited to participate if they: (a) were diagnosed with nephroblastoma or neuroblastoma between January 1990 and December 2012, (b) had the diagnosis before the age of 18, (c) were treated with anthracyclines, and (d) had participated in one of the nephroblastoma trials SIOP 9/GPOH, SIOP 93-01/GPOH, or SIOP 2001/GPOH or neuroblastoma trials NB 90, NB 97, or NB 2004.
Exclusion Criteria
Non-consent
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of high vs. moderate and low genetic risk of anthracycline-associated cardiotoxicity (according to RARG rs2229774, UGT1A6 rs17863783and SLC28A3 rs7853758 genotypes) with the incidence of anthracycline-associated cardiomyopathy, as confirmed by echocardiography. Echocardiography is performed as part of routine follow-up examinations within 12 months from inclusion of the patient.
- Secondary Outcome Measures
Name Time Method Comparison of the pharmacogenetic profile (candidate genes and genome-wide) between patients without and patients with anthracycline-associated cardiotoxicity, as confirmed by echocardiography. Echocardiography is performed as part of routine follow-up examinations within 12 months from inclusion of the patient.