UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041934 |
|---|---|
| Receipt number | R000047856 |
| Scientific Title | observational study for patients with pancreatic cancer |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2021/03/29 14:19:09 |
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Basic information
Public title
observational study for patients with pancreatic cancer
Acronym
observational study for patients with pancreatic cancer
Scientific Title
observational study for patients with pancreatic cancer
Scientific Title:Acronym
observational study for patients with pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey patients with pancreatic cancer about their treatment and social anxiety, information, image and satisfaction regarding the treatment of pancreatic cancer.
Clarify the greatest anxiety of patients with pancreatic cancer and examine unmet needs for treatment.
Basic objectives2
Others
Basic objectives -Others
Non-interventional observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relevance between anxiety of patients with pancreatic cancer and their needs for treatment options.
Key secondary outcomes
1) Basic and background information of patient with pancreatic cancer
2) Relevance between information required by pancreatic cancer patients and information tools.
3) Relevance between anxiety of patients with pancreatic cancer and necessary information and support which are wanted by patient.
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
1) Patients 20 years of age or older with a diagnosis of pancreatic cancer
2) Patients who have been treated for pancreatic cancer
3) Patients who have given their voluntary consent to participate in the study by filling out the participation form on the web questionnaire
Key exclusion criteria
1) Patients or their family members who are engaged in pharmaceutical, medical, or research occupations
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Naka |
Organization
Nihon Servier Co. Ltd
Division name
Medical affairs
Zip code
113-0033
Address
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5842-7111
masahiro.naka@servier.com
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Naka |
Organization
Nihon Servier Co. Ltd
Division name
Medical affairs
Zip code
113-0033
Address
Hongo MK Bldg., 1-28-34, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-5842-7111
Homepage URL
masahiro.naka@servier.com
Sponsor or person
Institute
Nihon Servier Co. Ltd
Institute
Department
Personal name
Funding Source
Organization
Nihon Servier Co. Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan conference of clinical research
Address
Ikebukuro YS building., 1-13-23, Minamiikebukuro, Toshima-ku, Tokyo.
Tel
03-6868-7022
jccr-info@jccr.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 | 10 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 11 | Month | 30 | Day |
Date analysis concluded
Other
Other related information
Clarify the relationship between patient background information and survey items.
Management information
Registered date
| 2020 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047856
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
