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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05633719
Other study ID # 2208-162-1354
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2022
Est. completion date June 30, 2026

Study information

Verified date November 2022
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date June 30, 2026
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 19 Years
Eligibility Inclusion Criteria: ? Solid cancer patients under the age of 19 receiving Platinum chemotherapy ? Solid cancer patients under the age of 19 receiving 30 Gy or more head and neck radiation therapy Exclusion Criteria: ? 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 ? Those who have difficulty in hearing test due to neurological factors, etc. ? Other cases judged to be inappropriate for this study by the judgment of the person in charge of the clinical trial

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Chemotherapy involving cisplatin or carboplatin
Chemotherapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of patients with ototoxic hearing loss Proportion of patients with ototoxic hearing loss in total patients 1 year after the initiation of chemotherapy
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