- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05633719
Multicenter, Prospective Observational Study for Early Diagnosis, and Development of Follow-up Protocol and Hearing Rehabilitation Program for Ototoxic Hearing Loss After Chemotherapy for Pediatric Solid Cancer
November 21, 2022 updated by: Moo Kyun, Park, Seoul National University Hospital
More than half of all pediatric cancer in Korea are solid cancer.
For the treatment of solid cancer, multidisciplinary methods such as surgery, chemotherapy, and radiation therapy are applied, and with the development of the treatment method, the treatment performance has improved dramatically, and the 5-year survival rate of more than 80% is currently recorded.
Due to the improvement in survival rate, interest in side effects caused by cancer treatment itself is gradually increasing, and efforts to reduce them are increasing.
Accordingly, it aims to contribute to improving the quality of life of pediatric solid cancer survivors.
by developing a Korean-type early diagnosis and follow-up protocol of ototoxic hearing loss, which commonly occurs in pediatric solid cancer who have undergone chemotherapy.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 17 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who are diagnosed as solid cancer and receive platinum chemotherapy
Description
Inclusion Criteria:
① Solid cancer patients under the age of 19 receiving Platinum chemotherapy
② Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy
Exclusion Criteria:
① Those who have received chemotherapy or radiation in the past
- Those who have difficulty understanding the clinical trial due to mental retardation or unable to read the consent form, such as illiteracy or foreigners ③ Those who have difficulty in hearing test due to neurological factors, etc. ④ Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pediatric solid cancer
|
Chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with ototoxic hearing loss
Time Frame: 1 year after the initiation of chemotherapy
|
Proportion of patients with ototoxic hearing loss in total patients
|
1 year after the initiation of chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 1, 2022
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
June 30, 2026
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
December 1, 2022
Study Record Updates
Last Update Posted (Actual)
December 1, 2022
Last Update Submitted That Met QC Criteria
November 21, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2208-162-1354
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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