Cancer and Hearing Loss Related in Children (OTOPLAT)
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|ClinicalTrials.gov Identifier: NCT02425397|
Recruitment Status : Unknown
Verified April 2015 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was: Active, not recruiting
First Posted : April 24, 2015
Last Update Posted : April 24, 2015
|Condition or disease||Intervention/treatment|
|Cancer in Children. Hearing Loss||Genetic: Genetic study Genetic: Genetic study MT-RN1|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||103 participants|
|Observational Model:||Case Control|
|Official Title:||Cancer and Deafness Associated With the Use of Platinum Derivatives in Children|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||March 2016|
|patients with grade 3 or 4 Brock ototoxicity||
Genetic: Genetic study
study of mutations of metabolic enzymes and membrane transport genes, which will be performed by sequencing.
|patients controls with no signs of ototoxicity||
Genetic: Genetic study MT-RN1
study of mutations of the mitochondrial gene MT-RN1, which will be performed by sequencing.
- genetic factors (drug metabolism enzymes, membrane transporters) predisposing to cisplatin and carboplatin ototoxicity in children [ Time Frame: Day 0 ]
- genetic factors predisposing to aminoglycoside ototoxicity; [ Time Frame: Day 0 ]
- To provide a rationale for prevention of ototoxicity by the use of antioxidant medications. [ Time Frame: Day 0 ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02425397
|Paris, France, 75005|