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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000041934
Receipt No. 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

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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
Email 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
Email masahiro.naka@servier.com

Sponsor
Institute Nihon Servier Co. Ltd
Institute
Department

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
Email 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
URL(English) https://upload.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
Registered date File name


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