UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042211 |
|---|---|
| Receipt number | R000048176 |
| Scientific Title | The impact of COVID-19 pandemic on colorectal cancer therapy |
| Date of disclosure of the study information | 2020/10/23 |
| Last modified on | 2020/10/22 18:02:42 |
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Basic information
Public title
The impact of COVID-19 pandemic on colorectal cancer therapy
Acronym
COVID-19 pandemic and colorectal cancer therapy
Scientific Title
The impact of COVID-19 pandemic on colorectal cancer therapy
Scientific Title:Acronym
The impact of COVID-19 pandemic on colorectal cancer therapy
Region
| Japan |
Condition
Condition
COVID-19, Colorectal cancer
Classification by specialty
| Infectious disease | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impact of COVID-19 pandemic on the characteristics of colorectal cancer patients and therapeutic approaches
Basic objectives2
Others
Basic objectives -Others
Retrospective studies using collected data
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The incidence of obstructive colorectal cancer
Key secondary outcomes
Patients' characteristics (Age, Sex, Emergency Admission, preoperative hemoglobin, preoperative CEA, Tumor location, pathological findings, residence, Events contributing to the detection of colorectal cancer), Numbers of surgery, colonoscopy and outpatients
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients are eligible for this study if they meet the following criteria.
Colorectal cancer patients who underwent surgery at participating institution
Those who do not refuse to participate in this study
Key exclusion criteria
Patients deemed ineligible as study participants by the research director
Target sample size
123
Research contact person
Name of lead principal investigator
| 1st name | Mizuno |
| Middle name | |
| Last name | Rei |
Organization
Uji-Tokushukai Medical Center
Division name
Department of Surgery
Zip code
611-0041
Address
145, Makishima-cho, ishibasi, Uji, Kyoto
TEL
0774201111
reimzn@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Mizuno |
| Middle name | |
| Last name | Rei |
Organization
Uji-Tokushukai Medical Center
Division name
Department of Surgery
Zip code
611-0041
Address
145, Makishima-cho, Ishibashi, Uji, Kyoto
TEL
0774201111
Homepage URL
reimzn@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Uji-Tokushukai Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Uji-Tokushukai Medical Center Institutional Review Board
Address
145, Makishima-cho, Ishibashi, Uji, Kyoto
Tel
0774201111
t.tumatani@ujitoku.or.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
| 2020 | Year | 10 | 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
123
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
| 2020 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2020 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048176
