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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000021799
Receipt No. R000025139
Scientific Title Survey of treatment strategy and analysis of prognostic factors in borderline resectable pancreatic cancer
Date of disclosure of the study information 2016/04/06
Last modified on 2016/04/06

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Basic information
Public title Survey of treatment strategy and analysis of prognostic factors in borderline resectable pancreatic cancer
Acronym Prognostic factors in borderline resectable pancreatic cancer
Scientific Title Survey of treatment strategy and analysis of prognostic factors in borderline resectable pancreatic cancer
Scientific Title:Acronym Prognostic factors in borderline resectable pancreatic cancer
Region
Japan

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

Objectives
Narrative objectives1 We survey the current status of the treatment strategy for borderline resectable pancreatic cancer in each facility. In addition, we investigate the prognostic factors of borderline resectable pancreatic cancerin a case series study.
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
Key secondary outcomes disease-free survival, neoadjuvant theraphy methods, completion rates of neoadjuvant theraphy, RECIST, CA19-9, SUVmax, Pathological effect, R0 resection rate, postoperative complications, postoperative diarrhea rate, readmission rate, completion rates of adjuvant theraphy, the administration period of adjuvant chemotherapy, patterns of recurrence

Base
Study type Others,meta-analysis etc

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Borderline resectable pancreatic cancer
Key exclusion criteria Unsuitable case in this study
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiko Tsuchida
Organization Tokyo Medical University
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code
Address 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Email akihikot@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Nagakawa
Organization Tokyo Medical University
Division name Department of Gastrointestinal and Pediatric Surgery
Zip code
Address 6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL 03-3342-6111
Homepage URL http://gakkai.co.jp/jsps43/index.html
Email naga@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

Funding Source
Organization None (Self-funding)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Participating institutions of Japanese Society of Pancreatic Surgery
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
2016 Year 04 Month 06 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
Date of protocol fixation
2016 Year 02 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Survay and case series study

Management information
Registered date
2016 Year 04 Month 06 Day
Last modified on
2016 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025139

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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