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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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

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
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. genetic factors (drug metabolism enzymes, membrane transporters) predisposing to cisplatin and carboplatin ototoxicity in children [ Time Frame: Day 0 ]

Secondary Outcome Measures :
  1. genetic factors predisposing to aminoglycoside ototoxicity; [ Time Frame: Day 0 ]
  2. To provide a rationale for prevention of ototoxicity by the use of antioxidant medications. [ Time Frame: Day 0 ]

Biospecimen Retention:   Samples With DNA
Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
180 patients will be included : 60 patients with grade 3 or 4 Brockototoxicityand 120 patients controls with no signs of ototoxicity (separate complete audiograms for each ear)
Criteria

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)

Information from the National Library of Medicine

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


Locations
France
Institut Curie
Paris, France, 75005
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02425397     History of Changes
Other Study ID Numbers: 2010-A00405-34
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Ototoxicity
platinum derivatives
paediatrics
oncology
clinical research

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms