UMIN-ICDS 臨床試験登録情報の閲覧

一般向け試験名/Public title

日本語
新型コロナウィルスのがん診療への影響

英語
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

日本語
新型コロナウィルスのがん診療への影響

英語
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

日本語
新型コロナウィルスのがん診療への影響

英語
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

日本語
新型コロナウィルスのがん診療への影響

英語
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

対象疾患名/Condition

日本語
がん

英語
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/Obstetrics 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1/Narrative objectives1

日本語
英語参照

英語
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

日本語
英語参照

英語
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

主要アウトカム評価項目/Primary outcomes

日本語
英語参照

英語
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

日本語

英語

試験の種類/Study type

その他・メタアナリシス等/Others,meta-analysis etc

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

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

日本語

英語

介入2/Interventions/Control_2

日本語

英語

介入3/Interventions/Control_3

日本語

英語

介入4/Interventions/Control_4

日本語

英語

介入5/Interventions/Control_5

日本語

英語

介入6/Interventions/Control_6

日本語

英語

介入7/Interventions/Control_7

日本語

英語

介入8/Interventions/Control_8

日本語

英語

介入9/Interventions/Control_9

日本語

英語

介入10/Interventions/Control_10

日本語

英語

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

日本語
英文参照

英語
Patients who were given the diagnosis of cancers, treated for cancers, and died from cancers.

除外基準/Key exclusion criteria

日本語
英文参照

英語
Not set.

目標参加者数/Target sample size

責任研究者/Name of lead principal investigator

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

所属組織/Organization

日本語
横浜市立大学附属病院

英語
Yokohama City University Hospital

所属部署/Division name

日本語
化学療法センター

英語
Chemotherapy Center

郵便番号/Zip code

236-0004

住所/Address

日本語
横浜市金沢区福浦3－9

英語
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担当者/Name of contact person

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

組織名/Organization

日本語
横浜市立大学附属病院

英語
Yokohama City University Hospital

部署名/Division name

日本語
化学療法センター

英語
Chemotherapy Center

郵便番号/Zip code

236-0004

住所/Address

日本語
横浜市金沢区福浦3-9

英語
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

機関名/Institute

日本語
その他

英語
Yokohama City University Hospital

機関名/Institute
（機関選択不可の場合）

日本語
横浜市立大学附属病院

部署名/Department

日本語

個人名/Personal name

日本語

英語

機関名/Organization

日本語
その他

英語
Yokohama City University Hospital

機関名/Organization
（機関選択不可の場合）

日本語
横浜市立大学附属病院

組織名/Division

日本語

組織の区分/Category of Funding Organization

その他/Other

研究費拠出国/Nationality of Funding Organization

日本語

英語

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

組織名/Organization

日本語
IRBなし

英語
IRB not required

住所/Address

日本語
IRBなし

英語
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

いいえ/NO

試験ID1/Study ID_1

ID発行機関1/Org. issuing International ID_1

日本語

英語

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

治験届/IND to MHLW

試験実施施設名称/Institutions

一般公開日（本登録希望日）/Date of disclosure of the study information

2021

年

12

月

07

日

プロトコル掲載URL/URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/?term=nobuyuki+horita+cancer+covid&sort=date

試験結果の公開状況/Publication of results

未公表/Unpublished

結果掲載URL/URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/?term=nobuyuki+horita+cancer+covid&sort=date

組み入れ参加者数/Number of participants that the trial has enrolled

523000

主な結果/Results

日本語
下記参照
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

英語
See below:
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

主な結果入力日/Results date posted

2024

年

04

月

03

日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

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

日本語
下記参照
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

英語
See below:
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

参加者の流れ/Participant flow

日本語
下記参照
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

英語
See below:
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

有害事象/Adverse events

日本語
下記参照
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

英語
See below:
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

評価項目/Outcome measures

日本語
下記参照
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

英語
See below:
Horita N, Chen H, Fukumoto T. Impact of the COVID-19 Pandemic on Cancer Treatment: Nationwide Japanese Registration until 2021. J Am Coll Surg. 2023 Aug 1;237(2):380-381. PMID: 37070756
Horita N. Impact of the COVID-19 pandemic on cancer diagnosis and resection in a COVID-19 low-burden country: Nationwide registration study in Japan. Eur J Cancer. 2022 Apr;165:113-115. PMID: 35231766

個別症例データ共有計画/Plan to share IPD

日本語

英語

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

日本語

英語

試験進捗状況/Recruitment status

主たる結果の公表済み/Main results already published

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

その他関連情報/Other related information

日本語
英文参照

英語
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.

登録日時/Registered date

2021

年

12

月

07

日

最終更新日/Last modified on

2024

年

04

月

03

日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000052842

英語
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052842