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UMIN-CTR 臨床試験登録情報の閲覧 |
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利用者名: | UMIN ID: |
試験進捗状況 | 一般募集中/Open public recruiting |
UMIN試験ID | UMIN000046307 |
受付番号 | R000052842 |
科学的試験名 | 新型コロナウィルスのがん診療への影響 |
一般公開日(本登録希望日) | 2021/12/07 |
最終更新日 | 2021/12/09 |
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 |
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対象疾患/Condition | ||||||||||
対象疾患名/Condition | がん | Cancer | ||||||||
疾患区分1/Classification by specialty |
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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 |
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年齢(上限)/Age-upper limit |
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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 |
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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 |
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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 |
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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 |
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倫理委員会による承認日/Date of IRB |
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登録・組入れ開始(予定)日/Anticipated trial start date |
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フォロー終了(予定)日/Last follow-up date |
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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 |
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最終更新日/Last modified on |
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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 |