UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000046307
Receipt number	R000052842
Scientific Title	Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.
Date of disclosure of the study information	2021/12/07
Last modified on	2024/04/03 14:16:35

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Basic information

Public title

Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.

Acronym

Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.

Scientific Title

Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.

Scientific Title:Acronym

Impact of COVID-19 pandemic on cancer diagnosis, treatment, and death in Japan: national-level registration study.

Region

Japan

Condition

Cancer

Classification by specialty

Medicine in general Surgery in general Obstetrics and Gynecology

Dermatology Oto-rhino-laryngology Urology

Laboratory medicine Operative medicine

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

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.

Basic objectives2

Others

Basic objectives -Others

to evaluate how the COVID-19 pandemic has affected the number of diagnoses, treatments, and deaths of various cancers.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

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

Key secondary outcomes

Base

Study type

Others,meta-analysis etc

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

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

Key exclusion criteria

Not set.

Target sample size

Research contact person

Name of lead principal investigator

1st name Nobuyuki

Middle name

Last name Horita

Organization

Yokohama City University Hospital

Division name

Chemotherapy Center

Zip code

236-0004

Address

3-9, Fukuura, Kanazawa, Yokohama

TEL

0457872800

Email

horitano@yokohama-cu.ac.jp

Public contact

Name of contact person

1st name Nobuyuki

Middle name

Last name Horita

Organization

Yokohama City University Hospital

Division name

Chemotherapy Center

Zip code

236-0004

Address

3-9, Kanazawa, Fukuura, Yokohama

TEL

0457872800

Homepage URL

Email

horitano@yokohama-cu.ac.jp

Sponsor or person

Institute

Yokohama City University Hospital

Institute

Department

Personal name

Funding Source

Organization

Yokohama City University Hospital

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

IRB not required

Address

IRB not required

Tel

045-787-2800

Email

horitano@yokohama-cu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2021 Year 12 Month 07 Day

Related information

URL releasing protocol

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

Publication of results

Unpublished

Result

URL related to results and publications

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

Number of participants that the trial has enrolled

523000

Results

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

Results date posted

2024 Year 04 Month 03 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Main results already published

Date of protocol fixation

2021 Year 12 Month 07 Day

Date of IRB

2021 Year 12 Month 07 Day

Anticipated trial start date

2021 Year 12 Month 07 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

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.

Management information

Registered date

2021 Year 12 Month 07 Day

Last modified on

2024 Year 04 Month 03 Day

Link to view the page

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

Medicine in general	Surgery in general	Obstetrics and Gynecology
Dermatology	Oto-rhino-laryngology	Urology
Laboratory medicine	Operative medicine