UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057889 |
|---|---|
| Receipt number | R000066164 |
| Scientific Title | A Systematic Review and Bivariate Meta-analysis of the Diagnostic Accuracy of Nucleic Acid Amplification Tests (NAATs) for Ocular Infections Caused by Chlamydia trachomatis |
| Date of disclosure of the study information | 2025/05/17 |
| Last modified on | 2025/05/17 16:38:49 |
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Basic information
Public title
Systematic Review and Meta-analysis on the Diagnostic Accuracy of Nucleic Acid Amplification Tests (NAATs) for Ocular Chlamydia Infections
Acronym
Meta-analysis of NAAT Accuracy for Ocular Chlamydia
Scientific Title
A Systematic Review and Bivariate Meta-analysis of the Diagnostic Accuracy of Nucleic Acid Amplification Tests (NAATs) for Ocular Infections Caused by Chlamydia trachomatis
Scientific Title:Acronym
Bivariate Meta-analysis of NAATs for Chlamydial Ocular Infections
Region
| Japan |
Condition
Condition
Chlamydial conjunctivitis (ocular Chlamydia infection)
Classification by specialty
| Infectious disease | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the diagnostic accuracy of nucleic acid amplification tests (NAATs) for ocular infections caused by Chlamydia trachomatis.
Basic objectives2
Others
Basic objectives -Others
The objective is to evaluate the diagnostic accuracy (sensitivity and specificity) of nucleic acid amplification tests (NAATs) for ocular infections caused by Chlamydia trachomatis through a meta-analysis of existing literature.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity and specificity of NAATs for the diagnosis of chlamydial ocular infections
Key secondary outcomes
Area under the SROC curve (AUC), diagnostic odds ratio (DOR), and heterogeneity (I^2)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Original articles evaluating the diagnostic accuracy (sensitivity and specificity) of nucleic acid amplification tests (NAATs) for ocular infections caused by Chlamydia trachomatis, including case-control, cross-sectional, prospective, and retrospective studies. Eligible studies must use conjunctival swabs or ocular discharges as specimens, and reference standards such as clinical diagnosis by physicians, culture methods, or DFA. Literature search will be conducted using PubMed and Web of Science, supplemented by manual reference and guideline review.
Key exclusion criteria
Studies reporting only sensitivity or specificity, which are insufficient for bivariate meta-analysis, will be excluded. In addition, duplicate studies judged to be based on the same dataset will be carefully reviewed and excluded if necessary.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University Hospital
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872683
mizuki.yuk.xj@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Mizuki |
Organization
Yokohama City University Hospital
Division name
Department of Ophthalmology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, Kanagawa, Japan
TEL
0457872683
Homepage URL
mizuki.yuk.xj@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University School of Medicine Department of Ophthalmology and Visual Science
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, JAPAN
Tel
0457872683
mizuki.yuk.xj@yokohama-cu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Kanagawa
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a systematic review and bivariate meta-analysis aimed at evaluating the diagnostic accuracy (sensitivity and specificity) of nucleic acid amplification tests (NAATs) for ocular infections caused by Chlamydia trachomatis. Two independent reviewers will conduct a literature search using PubMed and Web of Science. The area under the SROC curve (AUC) and the diagnostic odds ratio (DOR) will be analyzed.
Management information
Registered date
| 2025 | Year | 05 | Month | 16 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066164
