UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043515 |
|---|---|
| Receipt number | R000049687 |
| Scientific Title | Appraisal of relation between preoperative psychosocial status and surgical results in patients with gastrointestinal cancers |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2021/03/03 20:40:22 |
* 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
Appraisal of relation between preoperative psychosocial status and surgical results in patients with gastrointestinal cancers
Acronym
Appraisal of relation between preoperative psychosocial status and surgical results in patients with gastrointestinal cancers
Scientific Title
Appraisal of relation between preoperative psychosocial status and surgical results in patients with gastrointestinal cancers
Scientific Title:Acronym
Appraisal of relation between preoperative psychosocial status and surgical results in patients with gastrointestinal cancers
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We aim to evaluate whether positive affect is associated with better surgical outcomes for gastrointestinal cancers.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comprehensive complication index
Key secondary outcomes
Overall survival, QOL
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
Preoperative patients with gastrointestinal cancers
Key exclusion criteria
None
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Ebata |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2217
tomoki@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Shunsuke |
| Middle name | |
| Last name | Onoe |
Organization
Nagoya University Graduate School of Medicine
Division name
Division of Surgical Oncology, Department of Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
+81-52-744-2217
Homepage URL
sonoe@med.nagoya-u.ac.jp
Sponsor or person
Institute
Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate 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
Human Research Review Committee of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
+81-52-741-2111
ethics@med.nagoya-u.ac.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 | 05 | Month | 01 | 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
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
Preinitiation
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 03 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049687
