UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051148 |
|---|---|
| Receipt number | R000058330 |
| Scientific Title | Impact of the COVID-19 pandemic on time to treatment initiation of colorectal cancer in Japan |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 23:12:29 |
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Basic information
Public title
Impact of the COVID-19 pandemic on time to treatment initiation of colorectal cancer in Japan
Acronym
Impact of the COVID-19 on CRC
Scientific Title
Impact of the COVID-19 pandemic on time to treatment initiation of colorectal cancer in Japan
Scientific Title:Acronym
Impact of the COVID-19 on CRC
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This retrospective study aims to evaluate differences of diagnosis and treatment of colorectal cancer between the two years before and after the COVID-19 pandemic firstly happened in April 2020.
Basic objectives2
Others
Basic objectives -Others
time to treatment initiation (TTI) for two years before and after COVID-19 spread.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the number of surgeries and short-term outcomes as well as change in time to treatment initiation (TTI) for two years COVID-19 spread period compared with the same two years before the pandemic.
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
Colorectal cancer surgery
Key exclusion criteria
NA
Target sample size
383
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Tamura |
Organization
National Hospital Organization Osaka Minami Medical Center
Division name
Department of Surgery
Zip code
5868521
Address
2-1, Kidohigashicho, Kawachinagano city, Osaka 586-8521, Japan
TEL
0721535761
kotamura@ommc-hp.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Tamura |
Organization
National Hospital Organization Osaka Minami Medical Center
Division name
Department of Surgery
Zip code
5868521
Address
2-1, Kidohigashicho, Kawachinagano city, Osaka 586-8521, Japan
TEL
0721535761
Homepage URL
kotamura@ommc-hp.jp
Sponsor or person
Institute
National Hospital Organization Osaka Minami Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Osaka Minami Medical Center
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Minami Medical Center
Address
2-1, Kidohigashicho, Kawachinagano city, Osaka 586-8521, Japan
Tel
0721535761
kotamura@ommc-hp.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
| 2023 | Year | 05 | Month | 23 | 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
383
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
| 2018 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective observational cohort
Management information
Registered date
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058330
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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