Clinical trial · Observational
Cancer and Hearing Loss Related in Children
Cancer and Deafness Associated With the Use of Platinum Derivatives in Children
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A limited number of relatively contradictory studies have suggested that the development of serious ototoxicity in children treated with cisplatin or, more rarely, carboplatin could be partly related to genetic risk factors affecting detoxification enzymes and membrane transporters of platinum derivatives. The objective of this study is therefore to identify genetic variants associated with the development of platinum ototoxicity in patients treated with cisplatin or carboplatin (minimum follow-up of 3 years) for one of the following diseases: neuroblastoma, hepatoblastoma, retinoblastoma, malignant germ cell tumour, osteosarcoma, high-risk or recurrent Wilms' tumour, non-parameningealrhabdomyosarcoma. A total of 180 patients, corresponding to 60 cases with grade 3 or 4 ototoxicity and 120 controls with no signs of ototoxicity (separate complete audiograms for each ear) will be included. A saliva sample will be used to obtain DNA for pharmacogenetic studies. The value of this study will be to define a population at high risk of developing ototoxicity in order to adapt treatment, or even develop preventive treatment of ototoxicity based on antioxidant medications
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer in Children | — | UNRESOLVED | — |
| Hearing Loss | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Genetic study | Genetic | — | UNRESOLVED |
| Genetic study MT-RN1 | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- patients with grade 3 or 4 Brock ototoxicity
- interventionNames
- Genetic: Genetic study
- label
- patients controls with no signs of ototoxicity
- interventionNames
- Genetic: Genetic study MT-RN1
Primary outcomes (1)
- measure
- genetic factors (drug metabolism enzymes, membrane transporters) predisposing to cisplatin and carboplatin ototoxicity in children
- timeFrame
- Day 0
Secondary outcomes (2)
- measure
- genetic factors predisposing to aminoglycoside ototoxicity;
- timeFrame
- Day 0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
Show eligibility criteria text
Inclusion Criteria: * previous treatment with cis-or carboplatin * Age equal to or greater than 4 years * the presence of a separate complete audiogram for each ear in order to define the Brock grade * informed and written consent of both parents or legal guardian * affiliation of the child to a social security scheme To patients: * previous treatment with platinum compounds for neuroblastoma, hepatoblastoma, pancreatoblastoma, retinoblastoma, germ cell tumor malignant osteosarcoma, Wilms high risk or relapsed non para-meningeal rhabdomyosarcoma with ototoxicity grade 3 or 4 Brock (Grade 3 - 40dB to 2000 Hz; Grade 4-40 dB at 1000 Hz) To patients controls * previous treatment with platinum compounds for neuroblastoma, hepatoblastoma, pancreatoblastoma, retinoblastoma, germ cell tumor malignant osteosarcoma, Wilms high risk or recurrence rhabdomyosarcoma non parameningeal without ototoxicity (grade 0 Brock) * minimum follow-up of 3 years after stopping treatment Exclusion Criteria: * patients with brain tumor * patients with tumor "paraméningée" (such as rhabdomyosarcoma of the rock) * patients with renal toxicity (≥ Grade 2) at the time of treatment with platinum-based * patients with pathological pre-treatment assessment of hearing * chemotherapy during * patients with cerebral or total body irradiation (Total Body Irradiation)
References
Publications (1)
- RESULTLui G, Bouazza N, Denoyelle F, Moine M, Brugieres L, Chastagner P, Corradini N, Entz-Werle N, Verite C, Landmanparker J, Sudour-Bonnange H, Pasquet M, Verschuur A, Faure-Conter C, Doz F, Treluyer JM. Association between genetic polymorphisms and platinum-induced ototoxicity in children. Oncotarget. 2018 Jul 20;9(56):30883-30893. doi: 10.18632/oncotarget.25767. eCollection 2018 Jul 20. PMID 30112115