UMIN-CTR 臨床試験登録情報の閲覧

基本情報/Basic information
一般向け試験名/Public title	新型コロナウィルスのがん診療への影響	Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.
一般向け試験名略称/Acronym	新型コロナウィルスのがん診療への影響	Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.
科学的試験名/Scientific Title	新型コロナウィルスのがん診療への影響	Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.
科学的試験名略称/Scientific Title:Acronym	新型コロナウィルスのがん診療への影響	Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.
試験実施地域/Region	日本/Japan

対象疾患/Condition
対象疾患名/Condition	がん	Cancer
疾患区分1/Classification by specialty	内科学一般/Medicine in general 外科学一般/Surgery in general 産婦人科学/Obsterics and gynecology 皮膚科学/Dermatology 耳鼻咽喉科学/Oto-rhino-laryngology 泌尿器科学/Urology 検査医学/Laboratory medicine 手術医学/Operative medicine
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	英語参照	While more than 5 million people have died worldwide due to COVID-19 infections during the first two years of the pandemic, it also had a significant impact on the medical care of other diseases. Deaths from non-COVID-19 infections greatly reduced thanks to mask wearing and hand washing. Cancer screening is conducted to prolong life expectancy through early detection and curative treatment of cancer. People who benefit most from cancer screenings for are those with risk genes and with high-risk lifestyle. Impact of the pandemic on diagnosis, treatment, and death of cancers is a serious concern of health care providers, policy makers, and the general public because cancer death is one of the leading causes of death in many countries. Actually, broad spectrum of oncological care was suspended to deal with critical COVID-19 patients. According to Bakouny et al., subjects who underwent cancer screening during the first peak of the pandemic in the New England area of the United States from March to June, 2020 declined to one-third compared to 3 months of other periods. Retrospective research of two hospitals in Yokohama, Japan, by Kuzuu et al. revealed that gastric cancer (-26.9%) and colorectal cancer (-13.5%) were decreased during March 2020 to December 2020. However, there was no study using a large-scale high-coverage data at the national level to evaluate how the COVID-19 pandemic has affected the number of diagnoses, treatments, and deaths of various cancers. This retrospective study was to investigate these outcomes using national-level Japanese registry.
目的2/Basic objectives2	その他/Others
目的2 -その他詳細/Basic objectives -Others	英語参照	to evaluate how the COVID-19 pandemic has affected the number of diagnoses, treatments, and deaths of various cancers.
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	英語参照	How the COVID-19 pandemic has affected the number of diagnoses, treatments, and deaths of various cancers in 2020 and 2021 in terms of percentage decrease/increase from estimation from previous years
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	Patients who were given the diagnosis of cancers, treated for cancers, and died from cancers.
除外基準/Key exclusion criteria	英文参照	Not set.
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	名 信之 ミドルネーム 姓 堀田	名 Nobuyuki ミドルネーム 姓 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, Fukuura, Kanazawa, Yokohama
電話/TEL	0457872800
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	名 信之 ミドルネーム 姓 堀田	名 Nobuyuki ミドルネーム 姓 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, Kanazawa, Fukuura, Yokohama
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	IRBなし	IRB not required
住所/Address	IRBなし	IRB not required
電話/Tel	045-787-2800
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	2021 年 12 月 07 日

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	一般募集中/Open public recruiting
プロトコル確定日/Date of protocol fixation	2021 年 12 月 07 日
倫理委員会による承認日/Date of IRB	2021 年 12 月 07 日
登録・組入れ開始（予定）日/Anticipated trial start date	2021 年 12 月 07 日
フォロー終了(予定)日/Last follow-up date	2022 年 12 月 31 日
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	The database on diagnosis and treatment will be provided by the Hospital-based Cancer Registry. Of the 24 registered cancers for which data are available for 2016-2020, the top 10 cancers in terms of number of patients affected in 2019 will be included in the analysis.. TNM clinical staging will be used. The number of deaths from each cancer will be derived from data from the Japanese government, e-STAT. For the number of deaths in 2021, we will estimate the number from data of six months since only data for January-June were available. For the number of diagnoses and treatments, the number of cases from 2016 to 2019 will be approximated by a regression line using the least squares method with only the year as an explanatory variable. This approximation formula will be used to estimate the number of cases in 2020, assuming that there was no COVID-19 pandemic. The change in the actual counted value in 2020 from the estimated value in 2020 will be regarded as the change due to COVID-19. The Thompson test will be used whether there is a significant decrease in case number if the year 2020 has the largest negative residuals. P = 0.05 will be used as the criterion for statistical significance. The same approximation method will be applied for the number of deaths. Death data from 2009-2019 will be used for linear regression. We will consider the actual increase from the estimation in 2020 and 2021 are attributed to the pandemic.

管理情報/Management information
登録日時/Registered date	2021 年 12 月 07 日
最終更新日/Last modified on	2021 年 12 月 09 日

閲覧ページへのリンク/Link to view the page
URL(日本語)	https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052842
URL(英語)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052842

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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