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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011478
Receipt No. R000013378
Scientific Title Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Date of disclosure of the study information 2013/08/13
Last modified on 2016/02/29

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Basic information
Public title Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Acronym The serum autoantibodies and the prognosis of patients with pancreatic cancer
Scientific Title Analysis of the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Scientific Title:Acronym The serum autoantibodies and the prognosis of patients with pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the association between the serum autoantibodies and the prognosis of patients with pancreatic cancer
Basic objectives2 Others
Basic objectives -Others Usefulness of serum autoantibodies as biomarkers
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes Disease-free survival

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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Written informed consent is acquired from all patients or proxies ofthe patients.
2.The age of the patients is from 20 to 80.
3.Patients with pathologically proven pancreatic cancer
4.Patients who receive surgical resection, chemotherapy, and/or chemoradiotherapy
Key exclusion criteria 1.Patients with an active concomitant malignancy
2.Estimated suvaival<1 month
3.Patients with severe heart, respiratory or liver failure
4.Patients with administration of steroids, immunosuppresive drugs or biological products
5.Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Miyake
Organization Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho Okayama, Japan
TEL +81-86-235-7219
Email miyakeyasuhiro@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hironari Kato
Organization Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences
Division name Gastroenterology and Hepatology
Zip code
Address 2-5-1 Shikata-cho Okayama, Japan
TEL +81-86-235-7219
Homepage URL
Email drkatocha@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 13 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study in which we evaluate the association between the serum antibodies and the prognosis of patients with pancreatic cancer

Management information
Registered date
2013 Year 08 Month 13 Day
Last modified on
2016 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013378

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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