UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033718 |
|---|---|
| Receipt number | R000038449 |
| Scientific Title | Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care |
| Date of disclosure of the study information | 2018/08/30 |
| Last modified on | 2021/08/17 13:49:23 |
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Basic information
Public title
Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Acronym
Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Scientific Title
Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Scientific Title:Acronym
Research on clinical practice and development and validation study of a nomogram to predict overall survival of patients with stage IV gastrointestinal cancer in local medical care
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a prognostic system for Stage IV esophageal cancer, gastric cancer, and colorectal cancer that can be used by both the primary physician and the patient in community medical care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall all survival
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
StageIV gastrointestinalcancer (esophagus cancer, gastric cancer, colorectal cancer)
Key exclusion criteria
case of missing data
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Michitaka |
| Middle name | |
| Last name | Honda |
Organization
Fukushima medical university
Division name
Department of minimally invasive surgical and medical oncology
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5322
mhonda1017@gmail.com
Public contact
Name of contact person
| 1st name | Hidetaka |
| Middle name | |
| Last name | Kawamura |
Organization
Fukushima medical university
Division name
Department of minimally invasive surgical and medical oncology
Zip code
963-8563
Address
7-115 Yatsuyamada, Koriyama, Fukushima
TEL
024-934-5322
Homepage URL
hidetaka0716.hk@gmail.com
Sponsor or person
Institute
Southern TOHOKU General Hospital
Institute
Department
Personal name
Funding Source
Organization
Southern TOHOKU General Hospital
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
Southern TOHOKU General Hospital
Address
7-115 Yatsuyamada, Koriyama, Fukushima
Tel
024-934-5322
kensyu@mt.strins.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
| 2018 | Year | 08 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2018 | Year | 08 | Month | 10 | Day |
Last modified on
| 2021 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038449
