UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039479 |
|---|---|
| Receipt number | R000043529 |
| Scientific Title | A Study on the Effect of Cancer Treatment on the Cognitive Abilities of Cancer Patients Using Natural Language Processing Techniques for Spoken Languages -Monitoring cognitive function during the perioperative period and early after discharge- |
| Date of disclosure of the study information | 2020/03/03 |
| Last modified on | 2022/12/28 11:11:59 |
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Basic information
Public title
A Study on the Effect of Cancer Treatment on the Cognitive Abilities of Cancer Patients Using Natural Language Processing Techniques for Spoken Languages -Monitoring cognitive function during the perioperative period and early after discharge-
Acronym
KOTOBAKARI CANCER study 2
Scientific Title
A Study on the Effect of Cancer Treatment on the Cognitive Abilities of Cancer Patients Using Natural Language Processing Techniques for Spoken Languages -Monitoring cognitive function during the perioperative period and early after discharge-
Scientific Title:Acronym
KOTOBAKARI CANCER study 2
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of cancer treatment on the cognitive ability of cancer patients by automatic analysis using natural language processing technology for spoken languageEvaluate. Assessment during the perioperative period and early after discharge.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vocabulary ability, Grammatical ability, Cognitive ability
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
Gastrointestinal cancer patients such as gastric cancer over 20 years old who undergo surgery after hospitalization.
Key exclusion criteria
Patients who are judged inappropriate by the doctor, such as no experience using a touch panel with a smartphone or tablet.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Isao |
| Middle name | |
| Last name | Miyashiro |
Organization
Osaka International Cancer Insitute
Division name
Cancer Control Center
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
+81-6-6945-1181
miyashir@biken.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Miyashiro |
Organization
Osaka International Cancer Insitute
Division name
Cancer Control Center
Zip code
5418567
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
TEL
+81-6-6945-1181
Homepage URL
miyashir@biken.osaka-u.ac.jp
Sponsor or person
Institute
Osaka International Cancer Insitute
Institute
Department
Personal name
Funding Source
Organization
Osaka International Cancer Insitute
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
IRB, Osaka International Cancer Institute
Address
3-1-69 Otemae, Chuo-ku, Osaka 541-8567, Japan
Tel
+81-6-6945-1181
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
| 2020 | Year | 03 | Month | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following tests will be performed using a tablet device for approximately one month from the time of admission to the first outpatient after discharge. Measurement of cognitive ability by automatic analysis using natural language processing technology by recording spoken language, standardized cognitive function test, psychological scale evaluation, etc.
Management information
Registered date
| 2020 | Year | 02 | Month | 14 | Day |
Last modified on
| 2022 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043529
