CompletedNot Applicable

Cancer and Hearing Loss Related in Children

France119 participantsStarted 2011-03-27

Plain-language summary

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

Who can participate

Age range4 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

genetic factors (drug metabolism enzymes, membrane transporters) predisposing to cisplatin and carboplatin ototoxicity in children

Timeframe: Day 0

Trial details

NCT IDNCT02425397

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-01-05

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