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試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000039255
受付番号 R000044767
科学的試験名 眼部帯状疱疹の眼合併症に対するハッチンソン徴候の予後的価値:系統的レビューとメタ分析
一般公開日(本登録希望日) 2020/01/29
最終更新日 2020/07/25

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title 眼部帯状疱疹の眼合併症に対するハッチンソン徴候の予後的価値:系統的レビューとメタ分析 Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
一般向け試験名略称/Acronym 眼部帯状疱疹の眼合併症に対するハッチンソン徴候の予後的価値:系統的レビューとメタ分析 Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
科学的試験名/Scientific Title 眼部帯状疱疹の眼合併症に対するハッチンソン徴候の予後的価値:系統的レビューとメタ分析 Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
科学的試験名略称/Scientific Title:Acronym 眼部帯状疱疹の眼合併症に対するハッチンソン徴候の予後的価値:系統的レビューとメタ分析 Prognostic value of Hutchinson's sign for ocular complications in herpes zoster ophthalmicus: a systematic review and meta-analysis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 眼部帯状疱疹 herpes zoster ophthalmicus
疾患区分1/Classification by specialty
内科学一般/Medicine in general 眼科学/Ophthalmology
皮膚科学/Dermatology 成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 眼部帯状疱疹患者の眼合併症に対するハッチンソン徴候の予後的価値を調べる。 This systematic review and meta-analysis aimed to investigate the prognostic value of Hutchinson's sign for ocular complications of herpes zoster ophthalmicus.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 該当しない N/A
試験の性質1/Trial characteristics_1
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase

評価/Assessment
主要アウトカム評価項目/Primary outcomes Occurrence of ocular involvement, defined as a sign of ocular manifestation (e.g. conjunctivitis, superficial keratitis, episcleritis, stromal keratitis, dendritic ulcer, scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis).

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.
Occurrence of ocular involvement, defined as a sign of ocular manifestation (e.g. conjunctivitis, superficial keratitis, episcleritis, stromal keratitis, dendritic ulcer, scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis).

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.
副次アウトカム評価項目/Key secondary outcomes Occurrence of severe ocular involvement (intraocular involvement: e.g. scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis)

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.
Occurrence of severe ocular involvement (intraocular involvement: e.g. scleritis, uveitis, vasculitis, optic neuritis, chorioretinitis, acute retinal necrosis)

Time point for analysis will be defined as 4 weeks or the closest time point to 4 weeks in a time span of 2 weeks to 6 months if data are not available.

基本事項/Base
試験の種類/Study type その他・メタアナリシス等/Others,meta-analysis etc

試験デザイン/Study design
基本デザイン/Basic design
ランダム化/Randomization
ランダム化の単位/Randomization unit
ブラインド化/Blinding
コントロール/Control
層別化/Stratification
動的割付/Dynamic allocation
試験実施施設の考慮/Institution consideration
ブロック化/Blocking
割付コードを知る方法/Concealment

介入/Intervention
群数/No. of arms
介入の目的/Purpose of intervention
介入の種類/Type of intervention
介入1/Interventions/Control_1

介入2/Interventions/Control_2

介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
18 歳/years-old 以上/<=
年齢(上限)/Age-upper limit

適用なし/Not applicable
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria Inclusion criteria were as follows: published and unpublished observational studies with a control, or controlled clinical studies, including only Abstracts or Letters; studies in any language, from any country, and including length of follow-up; and outpatients or inpatients suspected or diagnosed with acute herpes zoster ophthalmicus. Inclusion criteria were as follows: published and unpublished observational studies with a control, or controlled clinical studies, including only Abstracts or Letters; studies in any language, from any country, and including length of follow-up; and outpatients or inpatients suspected or diagnosed with acute herpes zoster ophthalmicus.
除外基準/Key exclusion criteria Exclusion criteria were as follows: case reports and case series; children and patients with existing uveitis, glaucoma, corneal, and retinal diseases. Exclusion criteria were as follows: case reports and case series; children and patients with existing uveitis, glaucoma, corneal, and retinal diseases.
目標参加者数/Target sample size 0

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
貴大
ミドルネーム
水田
Takahiro
ミドルネーム
Mizuta
所属組織/Organization 東京都立多摩総合医療センター Tokyo Metropolitan Tama Medical Center
所属部署/Division name 皮膚科 Department of Dermatology
郵便番号/Zip code 1838524
住所/Address 東京都府中市武蔵台2-8-29 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
電話/TEL +81423235111
Email/Email t.miz.cof.lif2120@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person
貴大
ミドルネーム
水田
Takahiro
ミドルネーム
Mizuta
組織名/Organization 東京都立多摩総合医療センター Tokyo Metropolitan Tama Medical Center
部署名/Division name 皮膚科 Department of Dermatology
郵便番号/Zip code 1838524
住所/Address 東京都府中市武蔵台2-8-29 2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
電話/TEL +81423235111
試験のホームページURL/Homepage URL
Email/Email t.miz.cof.lif2120@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 SRWS-PSG
機関名/Institute
(機関選択不可の場合)
SRWS-PSG
部署名/Department

研究費提供組織/Funding Source
機関名/Organization 無し N/A
機関名/Organization
(機関選択不可の場合)
N/A
組織名/Division
組織の区分/Category of Funding Organization 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization


その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization N/A N/A
住所/Address N/A N/A
電話/Tel N/A
Email/Email N/A

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2020 01 29

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 開始前/Preinitiation
プロトコル確定日/Date of protocol fixation
2020 01 01
倫理委員会による承認日/Date of IRB
登録・組入れ開始(予定)日/Anticipated trial start date
2020 02 01
フォロー終了(予定)日/Last follow-up date
2022 02 01
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information [Search method]
Electronic search
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL)

Other resources
World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov

Guidelines
1. European consensus-based (S2k) guideline on the management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis.
2. International Association for the Study of Pain (IASP) recommendations on management of herpes zoster

We will search for references in identified articles, and relevant authors will be contacted, if information is insufficient in the reports.

[Data extraction / Risk of bias assessment]
Two authors will independently extract data and assess risk of bias using the QUIPS tool (Hayden 2013).

[Meta-analysis]
We will implement using STATA. We will use random effects model.

We will create a "Summary of findings" table and will use the grades of recommendation, assessment, development, and evaluation (GRADE) approach to grade the certainty of the evidence.

We will include the following outcomes in the "Summary of findings" table:
1. Occurrence of ocular involvement
2. Ocular involvement: uveitis

[Subgroup analysis]
Perform the following subgroup analyses:
1. Patients' immune competence (HIV infection absent or present)
2. Point of first contact (up to and including 72 h from the onset of rash or longer than 72 h from the onset of rash)
3. Point of starting initial systemic antiviral drugs (up to and including 72 h from the first patient contact or longer than 72 h from the first patient contact)

[Sensitivity analysis]
Perform the following sensitivity analyses for the primary outcome:
1. Exclusion of unpublished studies (full reports versus Abstracts or unpublished articles)
2. Exclusion of studies defining Hutchinson's sign as the presence of rash only on the tip of the nose
[Search method]
Electronic search
MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials (CENTRAL)

Other resources
World Health Organization International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov

Guidelines
1. European consensus-based (S2k) guideline on the management of Herpes Zoster - guided by the European Dermatology Forum (EDF) in cooperation with the European Academy of Dermatology and Venereology (EADV), Part 1: Diagnosis.
2. International Association for the Study of Pain (IASP) recommendations on management of herpes zoster

We will search for references in identified articles, and relevant authors will be contacted, if information is insufficient in the reports.

[Data extraction / Risk of bias assessment]
Two authors will independently extract data and assess risk of bias using the QUIPS tool (Hayden 2013).

[Meta-analysis]
We will implement using STATA. We will use random effects model.

We will create a "Summary of findings" table and will use the grades of recommendation, assessment, development, and evaluation (GRADE) approach to grade the certainty of the evidence.

We will include the following outcomes in the "Summary of findings" table:
1. Occurrence of ocular involvement
2. Ocular involvement: uveitis

[Subgroup analysis]
Perform the following subgroup analyses:
1. Patients' immune competence (HIV infection absent or present)
2. Point of first contact (up to and including 72 h from the onset of rash or longer than 72 h from the onset of rash)
3. Point of starting initial systemic antiviral drugs (up to and including 72 h from the first patient contact or longer than 72 h from the first patient contact)

[Sensitivity analysis]
Perform the following sensitivity analyses for the primary outcome:
1. Exclusion of unpublished studies (full reports versus Abstracts or unpublished articles)
2. Exclusion of studies defining Hutchinson's sign as the presence of rash only on the tip of the nose

管理情報/Management information
登録日時/Registered date
2020 01 25
最終更新日/Last modified on
2020 07 25


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000044767
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044767

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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