UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026216 |
|---|---|
| Receipt number | R000030118 |
| Scientific Title | A study for evaluating comprehensive geriatric assessment tools in elderly people after endoscopic treatment. |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2022/03/25 11:43:07 |
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Basic information
Public title
A study for evaluating comprehensive geriatric assessment tools in elderly people after endoscopic treatment.
Acronym
prognostic outcome for elderly people
Scientific Title
A study for evaluating comprehensive geriatric assessment tools in elderly people after endoscopic treatment.
Scientific Title:Acronym
prognostic outcome for elderly people
Region
| Japan |
Condition
Condition
pharyngeal cancer
esophageal cancer
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationship between adverse events or prognosis and comprehensive geriatric assessment score before and after endoscopic treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in geriatric assessment score
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
| 75 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Elderly people over 74 years old who undergo endoscopic treatment for cancer of pharynx, esophagus, or stomach.
Key exclusion criteria
In case patients who deny to join this study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Ishihara |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncoloy
Zip code
5418567
Address
3-1-69, Ootemae, Chuo-ku, Osaka
TEL
06-6945-1181
ryu1486@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Okubo |
Organization
Osaka International Cancer Institute
Division name
Gastrointestinal Oncoloy
Zip code
5418567
Address
3-1-69, Ootemae, Chuo-ku, Osaka
TEL
06-6945-1181
Homepage URL
yuki-okubo@oici.jp
Sponsor or person
Institute
Osaka International Cancer Institute
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka International Cancer Institute
Address
3-1-69, Ootemae, Chuo-ku, Osaka
Tel
0669451181
rinri01@opho.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
| 2017 | Year | 02 | Month | 20 | 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
Suspended
Date of protocol fixation
| 2017 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2017 | Year | 02 | Month | 19 | Day |
Last modified on
| 2022 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030118
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
