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試験進捗状況 開始前/Preinitiation
UMIN試験ID UMIN000041664
受付番号 R000047560
科学的試験名 原発性肺腺癌と扁平上皮肺癌の識別における免疫染色マーカーの診断精度に関するメタアナリシス
一般公開日(本登録希望日) 2020/09/03
最終更新日 2020/09/03

※ 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 原発性肺腺癌と扁平上皮肺癌の識別における免疫染色マーカーの診断精度に関するメタアナリシス Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
一般向け試験名略称/Acronym 原発性肺腺癌と扁平上皮肺癌の識別における免疫染色マーカーの診断精度に関するメタアナリシス Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
科学的試験名/Scientific Title 原発性肺腺癌と扁平上皮肺癌の識別における免疫染色マーカーの診断精度に関するメタアナリシス Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
科学的試験名略称/Scientific Title:Acronym 原発性肺腺癌と扁平上皮肺癌の識別における免疫染色マーカーの診断精度に関するメタアナリシス Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
試験実施地域/Region
日本/Japan

対象疾患/Condition
対象疾患名/Condition 非小細胞肺癌 NSCLC
疾患区分1/Classification by specialty
呼吸器内科学/Pneumology 呼吸器外科学/Chest surgery
疾患区分2/Classification by malignancy 悪性腫瘍/Malignancy
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1 英文参照のこと Sensitivity and specificity are key metrics to understand the diagnostic test accuracy of immunohistochemical stain technique. Without knowing the sensitivity and specificity of each marker, pathologist cannot select appropriate immunohistochemical markers. In addition, these data are required to judge the pathological subtype of NSCLC when multiple markers indicate discrepant results. Numerous studies were conducted to reveal the diagnostic test accuracy of immunohistochemical markers. However, these articles reported highly diverse results. To our knowledge, a meta-analysis assessing diagnostic value of TTF--1 for metastases of pulmonary adenocarcinoma and a meta-analysis elucidating combined TTF-1 and Napsin A were published. However, no systematic review evaluated diagnostic test accuracy of each marker to distinguish adenocarcinoma and squamous cell carcinoma of lungs. Aim of the current systematic review and meta-analysis is to summarize data from the previous studies regarding diagnostic test accuracy of immunohistochemical markers that are used for distinguishing primary adenocarcinoma and squamous cell lung cancer of the lungs.

目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others 英文参照のこと Aim of the current systematic review and meta-analysis is to summarize data from the previous studies regarding diagnostic test accuracy of immunohistochemical markers that are used for distinguishing primary adenocarcinoma and squamous cell lung cancer of the lungs.
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 英文参照のこと Sensitivity, specificity, area under curve (AUC), and diagnostic odds ratio will be evaluated. If two or more of cutoffs are applied in an original article, all of weak, moderate, and strong positive will be collectively considered positive. To diagnose adenocarcinoma, both adenocarcinoma and adenosquamous carcinoma will be counted since adenosquamous carcinoma has adenocarcinoma component while large cell carcinoma and NSCLC not otherwise specified will not be counted as adenocarcinoma. Similar algorithm will be applied to diagnose squamous cell carcinoma.
If data for multiple clones, e.g. 8G7G3/1, SPT24, and SP141 clones of TTF-1, are available, the data of 8G7G3/1 will be selected for our analysis because 8G7G3/1 clone has been known to provide the best diagnostic odds ratio among the three clones. Subgroup analysis focusing on each clone will be also done.

副次アウトカム評価項目/Key secondary outcomes


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

適用なし/Not applicable
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 英文参照のこと We will include full article, brief report, and conference abstract published in any language that provide data for sensitivity and specificity by immunohistochemical markers to diagnose adenocarcinoma and squamous cell carcinoma of the lung. Case-control study design consisted of patients with adenocarcinoma and squamous cell carcinoma will be accepted though case-control design may be counted as risk of bias according to Quality Assessment of Diagnostic Accuracy Studies-2(QUADAS-2).
Target population will be patients with NSCLC. Commonly used pathological criteria will be accepted along with WHO 2015 criteria.
Patients with both surgical and biopsy specimens will be allowed. Specimen outside the lung such as lymph nodes and pleural effusion will be accepted. Immunocytochemical stein using pleural effusion cell block will be also accepted along with immunohistochemical stein.
Target immunohistochemical markers include P40, CK5/6, P63, and desmocollin-3 (DSC3) for squamous cell carcinoma and TTF-1, Napsin A, and cytokeratin 7 (CK7) for adenocarcinoma. Immunohistochemical technique using any commercially available antibodies and non-commercial antibodies will be accepted. Reference test should be pathological diagnosis by pathologists.
除外基準/Key exclusion criteria 英文参照のこと An article that provide data of either sensitivity or specificity will be excluded since bivariate analysis is not applicable to such data.
Specificity evaluated among lung cancer cases will not be used for our analysis because analysis including both NSCLC and small-cell lung cancer will underestimate the specificity of markers. Studies focusing on non-pulmonary cancers and metastatic lung cancer of non-pulmonary origin will be excluded. Similarly, studies that compared NSCLC subtypes and mesothelioma will not be accepted.
目標参加者数/Target sample size

責任研究者/Research contact person
責任研究者/Name of lead principal investigator
信之
ミドルネーム
堀田
Nobuyuki
ミドルネーム
Horita
所属組織/Organization 横浜市立大学附属病院 Yokohama City University Hospital
所属部署/Division name 化学療法センター Chemotherapy Center
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, Fikuura, Kanazawa, Yokohama, Japan
電話/TEL 045-787-2800
Email/Email horitano@yokohama-cu.ac.jp

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
信之
ミドルネーム
堀田
Nobuyuki
ミドルネーム
Horita
組織名/Organization 横浜市立大学附属病院 Yokohama City University Hospital
部署名/Division name 化学療法センター Chemotherapy Center
郵便番号/Zip code 236-0004
住所/Address 横浜市金沢区福浦3-9 3-9, Fikuura, Kanazawa, Yokohama, Japan
電話/TEL 0457872800
試験のホームページURL/Homepage URL
Email/Email horitano@yokohama-cu.ac.jp

実施責任組織/Sponsor
機関名/Institute その他 Yokohama City University Hospital
機関名/Institute
(機関選択不可の場合)
横浜市立大学附属病院
部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Yokohama City University Hospital
機関名/Organization
(機関選択不可の場合)
横浜市立大学附属病院
組織名/Division
組織の区分/Category of Funding Organization その他/Other
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 横浜市立大学化学療法センター IRB not approved
住所/Address 横浜市金沢区福浦3-9 3-9, Fikuura, Kanazawa, Yokohama
電話/Tel 0457872800
Email/Email horitano@yokohama-cu.ac.jp

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 09 03

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 09 03
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 09 03
フォロー終了(予定)日/Last follow-up date
2021 09 03
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 英文参照のこと Study overview
The protocol of this systematic review and meta-analysis of diagnostic test accuracy was composited following standard guidelines for systematic review of diagnostic test accuracy and PRISMA-DTA. Approval of Institutional Review Board was not required because of the nature of this study.

Study search
Four major electric databases, namely PubMed, Web of Science, Cochrane, and Embase will be searched on September 3, 2020. The following formula will be applied for PubMed: ((P40 OR deltaNp63 OR delta-NP63) OR (P63 OR DBR16.1) OR (ck5/6 OR Cytokeratin 5/6) OR (desmocollin 3 OR desmocollin-3 OR DSC3 OR DSC-3) OR (TTF1 OR TTF-1 OR Thyroid transcription factor-1 OR Thyroid transcription factor 1) OR (NapsinA OR Napsin A OR TA02 OR aspartic protease) OR (CK7 OR cytokeratin7 OR cytokeratin 7)) AND ((sensitivity AND specificity) OR (diagnostic test accuracy) OR (likelihood ratio) OR (sensitivity AND adenocarcinoma AND squamous)) AND (NSCLC OR lung OR pulmonary OR bronchial OR pleural OR respiratory OR bronchoscopy) AND (NSCLC OR adenocarcinoma OR squamous OR squamous-cell OR non-small OR non small).

Risk of bias
QUADAS2 was applied to assess the risk of bias in each study.

Statistics
Bivariate model will be used to obtain pooled sensitivity and specificity and to draw a summary receiver operating characteristic curves (SROC).
We will obtain DOR by DerSimonian-Laird random-model. Publication bias for DOR will be checked by visual inspection and by Begg-Kendall test after a funnel plot will be drawn uding RevMan ver. 5 (Cochrane, London, UK).
DOR will be calculated by "madauni" command ("netmeta" package of R project, Gerta Rucker, Denmark). Sensitivity and specificity will be pooled by "reitsma" command ("netmeta" package of R project, Gerta Rucker, Denmark). The statistical threshold for significance will set at 0.05.


管理情報/Management information
登録日時/Registered date
2020 09 03
最終更新日/Last modified on
2020 09 03


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=R000047560
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047560

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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