Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01372904
Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from a neoplastic disease for which the treatment protocol includes cisplatinum not previously delivered to them.
* The cumulative cisplatin dose would be at least 300mg.
Exclusion Criteria:
* Age \< 18 years.
* Existing or previous pathology of the external or middle ear avoiding IT drug delivery or the performance of DPOAEs testing.
* Retrocochlear hearing loss.
* Meniere's disease.
* Autoimmune Inner Ear Disease.
* fluctuating hearing loss.
* History of sudden sensory neural hearing loss.
* Previous radiation therapy to the head and neck region.
* Baseline average pure tone audiometry thresholds for 500-3000 Hz and 4000-8000 Hz greater than 40 dB.
* Average SNR below 6 dB for DPOAEs f2 frequencies 500-3000 Hz and 4000-8000 Hz.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01372904
Study Brief:
Protocol Section:
NCT01372904