UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053436 |
|---|---|
| Receipt number | R000058785 |
| Scientific Title | Web Questionnaire Survey Study on adverse effects of trifluridine/tipiracil for patients and doctors. |
| Date of disclosure of the study information | 2024/01/26 |
| Last modified on | 2024/01/23 09:24:25 |
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Basic information
Public title
Web Questionnaire Survey Study on adverse effects of trifluridine/tipiracil for patients and doctors.
Acronym
Web Questionnaire Survey Study on adverse effects of trifluridine/tipiracil for patients and doctors.
Scientific Title
Web Questionnaire Survey Study on adverse effects of trifluridine/tipiracil for patients and doctors.
Scientific Title:Acronym
Web Questionnaire Survey Study on adverse effects of trifluridine/tipiracil for patients and doctors.
Region
| Japan |
Condition
Condition
Colorectal cancer, Gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual state of adverse effects and supportive care by conducting a questionnaire survey on a website for doctors and patients regarding adverse effects of trifluridine/tipiracil. In addition, to verify whether or not there is a difference in perceptions between doctors and patients regarding the occurrence of adverse effects and supportive care.
Basic objectives2
Others
Basic objectives -Others
Observational Study
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The state of occurrence of adverse effects of trifluridine/tipiracil and the details of supportive care
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Doctors:
1) Doctors in Japan
2) Those whose main area of expertise is either gastroenterology, clinical oncology, gastrointestinal surgery or general surgery
* The main area of expertise is based on their self-reported information.
3) Those who work at a facility with 100 beds or more
4) Those who administered trifluridine/tipiracil to two or more patients with metastaticcolorectal cancer/ gastric cancer in the past year as a primary doctor
5) Those whose consent to participation in the study is obtained
Patients:
1) Adults living in Japan
2) Patients with gastric or colorectal cancer
3) Those who have taken trifluridine/tipiracil for gastric or colorectal cancer
4) Those who have received more than two prescriptions for trifluridine/tipiracil
5) Those whose last prescription for trifluridine/tipiracil was within the past six months
6) Those whose consent to participation in the study is expected to be obtained
Key exclusion criteria
Doctors:
1) Doctors who are external research advisors in this study
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hironari |
| Middle name | |
| Last name | Iwamoto |
Organization
TAIHO PHARMACEUTICAL CO., LTD.
Division name
Medical Affairs Dept.
Zip code
101-8044
Address
1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo
TEL
03-3294-4527
th-ftdtpirwd@taiho.co.jp
Public contact
Name of contact person
| 1st name | Haruhiko |
| Middle name | |
| Last name | Seki |
Organization
INTAGE Healthcare
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity 4-6 Kanda-Surugadai Chiyoda-ku Tokyo
TEL
03-5295-1579
Homepage URL
haruhiko.seki@intage.com
Sponsor or person
Institute
TAIHO PHARMACEUTICAL CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
TAIHO PHARMACEUTICAL CO., LTD.
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
Non-Profit Organization MINS Research Ethics Committee
Address
5-20-9-401 Mita Minato-ku Tokyo
Tel
03-6416-1868
npo-mins@j-irb.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
| 2024 | Year | 01 | Month | 26 | 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
| 2023 | Year | 12 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Web Questionnaire Study
Management information
Registered date
| 2024 | Year | 01 | Month | 25 | Day |
Last modified on
| 2024 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058785
| 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 |
