Cancer and Hearing Loss Related in Children (NCT02425397) | Clinical Trial Compass
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 range
4 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
genetic factors (drug metabolism enzymes, membrane transporters) predisposing to cisplatin and carboplatin ototoxicity in children