UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044597
Receipt number R000050941
Scientific Title The observational study of COVID-19 patients with cancer from Japanese registry database of COVID-19.
Date of disclosure of the study information 2021/06/20
Last modified on 2021/06/19 21:22:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The observational study to evaluate the prognostic value of malignancies in patients with COVID-19 from Japanese registry database of COVID-19.

Acronym

The observational study of COVID-19 patients with cancer from Japanese registry database of COVID-19.

Scientific Title

The observational study of COVID-19 patients with cancer from Japanese registry database of COVID-19.

Scientific Title:Acronym

The observational study of COVID-19 patients with cancer from Japanese registry database of COVID-19.

Region

Japan


Condition

Condition

COVID-19 and cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the influence on prognosis due to cancer in the COVID-19 patients in Japan.

Basic objectives2

Others

Basic objectives -Others

To investigate the poor prognostic factor in the patients with COVID-19 and cancer.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mortality rate in the COVID-19 patients with cancer.

Key secondary outcomes



Base

Study type

Observational


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

The patients who were enrolled in COVIREGI-JP.

Key exclusion criteria

1. The patients with missing data about survival information or cancer.
2. The patients who missed the essential data to be analyzed among other clinical data.

Target sample size

31364


Research contact person

Name of lead principal investigator

1st name Osamu
Middle name
Last name Hataji

Organization

Matsusaka Municipal Hospital

Division name

Respiratory Center

Zip code

5150073

Address

1550, Tonomachi

TEL

0598231515

Email

mch1031@matsusaka.city-hosp.ne.jp


Public contact

Name of contact person

1st name Kentaro
Middle name Ito
Last name Ito

Organization

Matsusaka Municipal Hospital

Division name

Respiratory Center

Zip code

5150073

Address

1550, Tonomachi

TEL

0598231515

Homepage URL


Email

kentarou_i_0214@yahoo.co.jp


Sponsor or person

Institute

Matsusaka Municipal Hospital

Institute

Department

Personal name



Funding Source

Organization

Matsusaka Municipal Hospital

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Matsusaka Municipal Hospital

Address

1550, Tonomachi

Tel

0598231515

Email

kentarou_i_0214@yahoo.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 20 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

31364

Results


Results date posted


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

No longer recruiting

Date of protocol fixation

2021 Year 01 Month 05 Day

Date of IRB

2020 Year 03 Month 02 Day

Anticipated trial start date

2021 Year 04 Month 26 Day

Last follow-up date

2021 Year 07 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a secondary use of data from the COVIREGI-JP study (UMIN000039873).


Management information

Registered date

2021 Year 06 Month 19 Day

Last modified on

2021 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050941


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name