Skip to content

Pharmacogenetic sub-study within the research project „Structure Optimization for Children with Cancer after Therapy with Anthracyclines (LESS-Anthra)“

Pharmacogenetic sub-study within the research project „Structure Optimization for Children with Cancer after Therapy with Anthracyclines (LESS-Anthra)“

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00015084
Enrollment
450
Registered
2019-01-22
Start date
2017-06-15
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA - 10048610: Cardiotoxicity C74 C64

Interventions

Group 1: After consenting to participate in the study, a biosample (blood or saliva) is obtained for DNA extraction and patients undergo an echocardiographic examination. Genotyping for candidate sing

Sponsors

Studienleiter des Late Effects Surveillance System (LESS)Klinik für Kinder- und Jugendmedizin, Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Non-consent

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Germany

Contacts

Public ContactOliver Zolk

Institut für Naturheilkunde & Klinische Pharmakologie,Universitätsklinikum Ulm

oliver.zolk@uni-ulm.de+49 (0) 731-500 65603

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 14, 2026