UMIN-ICDS Clinical Trial

Public title

Association Between Urinary and Salivary Cytomegalovirus DNA Load and Hearing Loss in Children with Congenital Cytomegalovirus Infection

Acronym

CMV DNA Load and Hearing Loss in cCMV

Scientific Title

Longitudinal association between urinary and salivary CMV DNA load and hearing outcomes in children with congenital cytomegalovirus infection

Scientific Title:Acronym

CMV-Load & Hearing Study

Region

Japan

Condition

Congenital Cytomegalovirus Infection

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Virological assessment
(1)Cytomegalovirus load in urine
(2)Cytomegalovirus load in saliva
(3)Longitudinal changes in viral load at each measurement time point

Audiological assessmen
(1)Hearing thresholds measured by auditory brainstem response(ABR), auditory-steady state response(ASSR), otoacoustic emissions(OAE), and pure-tone audiometry
(2)Longitudinal changes in hearing
(3)Presence and timing of delayed-onset hearing loss

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

46

Name of lead principal investigator

1st name	Masako
Middle name
Last name	Kitano

Organization

Mie University Hospital

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

0592321111

Email

machako@med.mie-u.ac.jp

Name of contact person

1st name	Masako
Middle name
Last name	Kitano

Organization

Mie University Hospital

Division name

Department of Otorhinolaryngology and Head and Neck Surgery

Zip code

5148507

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

0592321111

Homepage URL

Email

machako@med.mie-u.ac.jp

Institute

Mie University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Mie University Hospital

Address

2-174 Edobashi, Tsu, Mie, Japan

Tel

0592321111

Email

machako@med.mie-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

三重大学医学部附属病院（三重県）

Date of disclosure of the study information

2026

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

07

Month

01

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Children with congenital cytomegalovirus infection who visited the Department of Otolaryngology and Head and Neck Surgery at Mie University Hospital between the date of study approval and March 31, 2030, and who provided consent to participate in this study, will be included. CMV viral load in both saliva and urine will be measured in all participants at regular follow up visits. For each case, CMV viral load in urine and saliva, as well as hearing assessments, will be performed periodically during the observation period, and their longitudinal changes will be analyzed.

Registered date

2026

Year

04

Month

19

Day

Last modified on

2026

Year

04

Month

19

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070022