UMIN-CTR Clinical Trial

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