UMIN試験ID | UMIN000041664 |
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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 | 2022/11/18 16:13:25 |
日本語
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
英語
Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
日本語
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
英語
Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
日本語
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
英語
Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
日本語
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
英語
Immunohistochemical markers to differentiate primary adenocarcinoma and squamous cell carcinoma of the lung: diagnostic test accuracy meta-analysis
日本/Japan |
日本語
非小細胞肺癌
英語
NSCLC
呼吸器内科学/Pneumology | 呼吸器外科学/Chest surgery |
悪性腫瘍/Malignancy
いいえ/NO
日本語
英文参照のこと
英語
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.
その他/Others
日本語
英文参照のこと
英語
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.
日本語
英文参照のこと
英語
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.
日本語
英語
その他・メタアナリシス等/Others,meta-analysis etc
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
適用なし/Not applicable |
適用なし/Not applicable |
男女両方/Male and Female
日本語
英文参照のこと
英語
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.
日本語
英文参照のこと
英語
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.
日本語
名 | 信之 |
ミドルネーム | |
姓 | 堀田 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horita |
日本語
横浜市立大学附属病院
英語
Yokohama City University Hospital
日本語
化学療法センター
英語
Chemotherapy Center
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fikuura, Kanazawa, Yokohama, Japan
045-787-2800
horitano@yokohama-cu.ac.jp
日本語
名 | 信之 |
ミドルネーム | |
姓 | 堀田 |
英語
名 | Nobuyuki |
ミドルネーム | |
姓 | Horita |
日本語
横浜市立大学附属病院
英語
Yokohama City University Hospital
日本語
化学療法センター
英語
Chemotherapy Center
236-0004
日本語
横浜市金沢区福浦3-9
英語
3-9, Fikuura, Kanazawa, Yokohama, Japan
0457872800
horitano@yokohama-cu.ac.jp
日本語
その他
英語
Yokohama City University Hospital
日本語
横浜市立大学附属病院
日本語
日本語
英語
日本語
その他
英語
Yokohama City University Hospital
日本語
横浜市立大学附属病院
日本語
その他/Other
日本語
英語
日本語
英語
日本語
英語
日本語
横浜市立大学化学療法センター
英語
IRB not approved
日本語
横浜市金沢区福浦3-9
英語
3-9, Fikuura, Kanazawa, Yokohama
0457872800
horitano@yokohama-cu.ac.jp
いいえ/NO
日本語
英語
日本語
英語
2020 | 年 | 09 | 月 | 03 | 日 |
未公表/Unpublished
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
主たる結果の公表済み/Main results already published
2020 | 年 | 09 | 月 | 03 | 日 |
2000 | 年 | 09 | 月 | 03 | 日 |
2020 | 年 | 09 | 月 | 03 | 日 |
2021 | 年 | 09 | 月 | 03 | 日 |
日本語
英文参照のこと
英語
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.
2020 | 年 | 09 | 月 | 03 | 日 |
2022 | 年 | 11 | 月 | 18 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047560
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047560
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