UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043873 |
|---|---|
| Receipt number | R000050087 |
| Scientific Title | Effects of the COVID-19 Pandemic on the Gastrointestinal Cancer Stage at Diagnosis in Japan |
| Date of disclosure of the study information | 2021/04/09 |
| Last modified on | 2023/10/11 17:10:43 |
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Basic information
Public title
Effects of the COVID-19 Pandemic on the Gastrointestinal Cancer Stage at Diagnosis in Japan
Acronym
Effects of the COVID-19 Pandemic on the Gastrointestinal Cancer Stage at Diagnosis in Japan
Scientific Title
Effects of the COVID-19 Pandemic on the Gastrointestinal Cancer Stage at Diagnosis in Japan
Scientific Title:Acronym
Effects of the COVID-19 Pandemic on the Gastrointestinal Cancer Stage at Diagnosis in Japan
Region
| Japan |
Condition
Condition
Gastrointestinal Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the gastrointestinal cancer stage at diagnosis in Japan before and during the COVID-19 pandemic.
Basic objectives2
Others
Basic objectives -Others
To evaluate the gastrointestinal cancer stage at diagnosis in Japan before and during the COVID-19 pandemic.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Monthly numbers of newly diagnosed cancer patients were aggregated, classified by stage, and compared.
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
| 10 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients from a hospital-based cancer registry were included if they had newly diagnosed gastrointestinal cancer (esophageal, gastric, colorectal, pancreatic, liver, and biliary tract cancers) between January 2016 and December 2020.
Key exclusion criteria
Patients were considered eligible if they were diagnosed or started their first treatment (including palliative care) at the study hospitals and were considered ineligible if they were diagnosed and started their first treatment at other hospitals.
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | kento |
| Middle name | |
| Last name | Kuzuu |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
kentokuzuu@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Kuzuu |
Organization
Yokohama City University School of Medicine
Division name
Gastroenterology
Zip code
236-0004
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2640
Homepage URL
kentokuzuu@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Yokohama City University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
Yokohama City University School of Medicine
Address
3-9 Fukuura, Kanazawa-ku, Yokohama
Tel
(+81) 45-787-2640
kentokuzuu@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 | 04 | Month | 09 | Day |
Related information
URL releasing protocol
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784394
Publication of results
Published
Result
URL related to results and publications
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2784394
Number of participants that the trial has enrolled
5167
Results
The study evaluated 5167 patients. Comparing the preCOVID-19 period with the COVID-19 period, significant decreases were observed in the mean number of patients with newly diagnosed gastric cancer and colorectal cancer. Significant decreases were also observed in the mean number of cases of stage I gastric cancer, stage 0 colorectal cancer, and stage I colorectal cancer. A significant decrease was observed in the mean number of cases per month of stage II colorectal cancer.
Results date posted
| 2023 | Year | 10 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Objective
To evaluate stage at diagnosis among patients with gastrointestinal cancer in Japan before and during the COVID-19 pandemic.
Design, Setting, and Participant
This retrospective cohort study included patients in a hospital-based cancer registry who were diagnosed with gastrointestinal cancer (ie, esophageal, gastric, colorectal, pancreatic, liver, and biliary tract cancers) between January 2016 and December 2020 at 2 tertiary Japanese hospitals.
Exposures
The preCOVID-19 period was defined as January 2017 to February 2020, and the COVID-19 period was defined as March 2020 to December 2020.
Participant flow
Objective
To evaluate stage at diagnosis among patients with gastrointestinal cancer in Japan before and during the COVID-19 pandemic.
Design, Setting, and Participant
This retrospective cohort study included patients in a hospital-based cancer registry who were diagnosed with gastrointestinal cancer (ie, esophageal, gastric, colorectal, pancreatic, liver, and biliary tract cancers) between January 2016 and December 2020 at 2 tertiary Japanese hospitals.
Exposures
The preCOVID-19 period was defined as January 2017 to February 2020, and the COVID-19 period was defined as March 2020 to December 2020.
Adverse events
None
Outcome measures
Main Outcome and Measure
Monthly numbers of patients with newly diagnosed cancer were aggregated, classified by stage, and compared.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This retrospective study evaluated patients who were treated at the Yokohama City University Hospital and the National Hospital Organization Yokohama Medical Center between January 2017 and December 2020.
Management information
Registered date
| 2021 | Year | 04 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050087
