UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048678 |
|---|---|
| Receipt number | R000055469 |
| Scientific Title | Impact of guidelines and clinical trials on the surgeon's decision |
| Date of disclosure of the study information | 2022/08/16 |
| Last modified on | 2022/08/16 15:22:05 |
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Basic information
Public title
Impact of guidelines and clinical trials on the surgeon's decision
Acronym
Impact of guidelines and clinical trials on the surgeon's decision
Scientific Title
Impact of guidelines and clinical trials on the surgeon's decision
Scientific Title:Acronym
Impact of guidelines and clinical trials on the surgeon's decision
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the impact of the results of Phase III clinical trials and the publication of guidelines on surgeons' surgical decisions and on surgical outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of laparoscopic gastrectomy performed per month
Number of gastrectomy performed for Stage IV gastric cancer patients per month
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent gastrectomy for Stage I gastric cancer
Patients who underwent gastrectomy for Stage IV gastric cancer
Key exclusion criteria
Surgical procedure unknown
Date of surgery unknown
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Honda |
Organization
Fukushima Medical University
Division name
Minimally Invasive Surgical and Medical University
Zip code
960-1295
Address
Fukushima
TEL
0245471111
mhonda@fukushimamed.com
Public contact
Name of contact person
| 1st name | Michitaka |
| Middle name | |
| Last name | Honda |
Organization
Fukushima Medical University
Division name
Minimally Invasive Surgical and Medical University
Zip code
9601295
Address
Fukushima
TEL
0245471111
Homepage URL
mhonda@fukushimamed.com
Sponsor or person
Institute
Fukushima Medical University
Minimally Invasive Surgical and Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Fukushima medhical University
Address
Fukushima
Tel
0245471111
mhonda@fukushimamed.com
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
| 2022 | Year | 08 | Month | 16 | 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
64910
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
DPC data were retrospectively analyze
Management information
Registered date
| 2022 | Year | 08 | Month | 16 | Day |
Last modified on
| 2022 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055469
