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Trial Title:
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
NCT ID:
NCT05633719
Condition:
Solid Tumor, Childhood
Conditions: Official terms:
Hearing Loss
Deafness
Carboplatin
Conditions: Keywords:
Pediatric solid tumor, Chemotherapy, Hearing loss
Study type:
Observational [Patient Registry]
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Chemotherapy involving cisplatin or carboplatin
Description:
Chemotherapy
Arm group label:
Pediatric solid cancer
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.
Criteria for eligibility:
Study pop:
Patients who are diagnosed as solid cancer and receive platinum chemotherapy
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
19 Years
Healthy volunteers:
No
Start date:
December 1, 2022
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Seoul National University Hospital
Agency class:
Other
Source:
Seoul National University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05633719
