Tokyo, July 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061306) titled 'Association Between Urinary and Salivary Cytomegalovirus DNA Load and Hearing Loss in Children with Congenital Cytomegalovirus Infection' on July 1.
Study Type:
Observational
Primary Sponsor:
Institute - Mie University
Condition:
Condition - Congenital Cytomegalovirus Infection
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To clarify the association between cytomegalovirus load in urine and saliva and (1) hearing fluctuation (improvement, no change, or deterioration) in children with congenital hearing loss, and (2) the onset of delayed-onset hearing loss in children without congenital hearing loss, among children with congenital cytomegalovirus infection.
Basic objectives2 - Bio-availability
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients diagnosed with congenital cytomegalovirus infection (cCMVI)
Patients in whom serial measurements of CMV viral load in urine and/or saliva are feasible
Patients who can undergo regular audiological evaluations
Patients whose clinical background information can be confirmed from medical records
Patients from whom written informed consent (including assent, when applicable) has been obtained
Key exclusion criteria - Patients with other identifiable causes of hearing loss
Patients who are lost to follow-up and for whom longitudinal evaluation is not feasible
Patients with substantially missing essential clinical information
Patients deemed inappropriate for inclusion in the study by the principal investigator
Target Size - 46
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 07 Month 01 Day
Anticipated trial start date - 2026 Year 07 Month 01 Day
Last follow-up date - 2030 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070022
Disclaimer: Curated by HT Syndication.