An observational study in Ototoxicity and Unspecified Childhood Solid Tumor, Protocol Specific, sponsored by Children's Oncology Group. Completed at 81 sites in 3 countries. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by Children's Oncology Group · Observational
RATIONALE: New ways to find out about hearing loss after treatment with chemotherapy may improve the ability to plan cancer treatment and may help patients live more comfortably.
PURPOSE: This clinical trial is assessing ear damage in young cancer patients treated with cisplatin.
OBJECTIVES:
OUTLINE: This is a multicenter, prospective, cohort study.
Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin.
Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests before the transplantation and 4 weeks after transplantation.
PROJECTED ACCRUAL: A total of 282 patients will be accrued for this study.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's enrollment of 301 is above the median of 111 across 14 observational studies indexed under Ototoxicity.
Browse Ototoxicity studies →Children's Oncology Group is the lead sponsor of 448 studies on the registry; 36 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer or planning to enroll on clinical trial ACCL0431
DISEASE CHARACTERISTICS:
Planning to undergo treatment with any cisplatin-containing therapeutic regimen for cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients undergo hearing tests (conventional, otoscopy, ultrahigh frequency, and otoacoustic emission testing) for management of therapy complications before the first course of planned cisplatin, before each subsequent course of cisplatin, and 4 weeks after the last dose of cisplatin. Patients who are scheduled to receive hematopoietic progenitor stem cell transplantation undergo hearing tests for management of therapy complications before the transplantation and 4 weeks after transplantation.
Procedure: management of therapy complications
Undergo hearing tests
Also known as: complications of therapy, management of
Incidence of patients with ototoxicity according to Common Toxicity Criteria, American-Speech-Language-Hearing Association, and Brock's criteria
Time frame: Length of study
Proportion of patients who undergo assessments using ultrahigh frequency (UHF) and evoked otoacoustic emission (OAE) testing
Time frame: Length of study
Proportion of patients with complete standard audiometry data (excluding UHF and OAE evaluations)
Time frame: Length of Study
The record gives a start of May 2007, a primary completion of Jan 2015 and a completion of Feb 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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