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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000006574
Receipt No. R000007775
Scientific Title The exploratory study of the relationship between psychiatric problems and organic brain abnormalities in patients with pancreatic cancer.
Date of disclosure of the study information 2011/10/18
Last modified on 2015/10/19

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Basic information
Public title The exploratory study of the relationship between psychiatric problems and organic brain abnormalities in patients with pancreatic cancer.
Acronym The relationship between psychiatric problems and organic abnormalities in patients with pancreatic cancer.
Scientific Title The exploratory study of the relationship between psychiatric problems and organic brain abnormalities in patients with pancreatic cancer.
Scientific Title:Acronym The relationship between psychiatric problems and organic abnormalities in patients with pancreatic cancer.
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between psychiatric problems and organic brain abnormalities.
Basic objectives2 Others
Basic objectives -Others relationship
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The prevalence of psychiatric problems in patients with pancreatic cancer.
Key secondary outcomes Sociodemografic data of pancreatic cancer patients with psychiatric problems.
Changes of imaging findings, cagulation ability, immunity, neurotrophic facters.

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 In-patient with suspected pancreatic cancer are included.
Cases with written and oral informed consent are included.
Key exclusion criteria Cases with non-pancreatic cancer are excluded, even after inclusion with clinical suspicious.
Evident dementia,and so on.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Hirooka
Organization Nagoya University Hospital
Division name Department of Endoscopy
Zip code
Address 65,Tsuruma-cho, Showa-ku, Nagoya,Aichi,Japan
TEL 052-744-2111
Email hirooka@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Sugimoto
Organization Nagoya University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 65,Tsuruma-cho, Showa-ku, Nagoya,Aichi,Japan
TEL 052-741-2111
Homepage URL
Email sugi3@med.nagoya-u.ac.jp

Sponsor
Institute Department of Gastroenterology, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2011 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results This prospective study showed that most domains of HRQOL were maintained until 6 months after the start of treatment, and that the baseline score for pain was a significant prognostic factor for survival in patients with pancreatic cancer who received early psychiatric intervention.
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 Main results already published
Date of protocol fixation
2011 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2015 Year 03 Month 30 Day
Date of closure to data entry
2015 Year 03 Month 30 Day
Date trial data considered complete
2015 Year 03 Month 30 Day
Date analysis concluded
2015 Year 04 Month 30 Day

Other
Other related information prospective study

Management information
Registered date
2011 Year 10 Month 18 Day
Last modified on
2015 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007775

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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