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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035454
Receipt No. R000040393
Scientific Title Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Date of disclosure of the study information 2019/01/05
Last modified on 2019/01/05

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Basic information
Public title Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Acronym HOPS-UR
Scientific Title Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Scientific Title:Acronym HOPS-UR
Region
Japan

Condition
Condition Pancreatic adenocarcinoma (PDAC), unresectable (UR)
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 The aim of this study was to evaluate outcomes of patients who were clinically diagnosed as UR-PDAC.
Basic objectives2 Others
Basic objectives -Others To assess the outcomes of patients who were clinically diagnosed as UR-PDAC and were treated in tertiary referral hospitals around Hokkaido prefecture.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Conversion rate to radical surgeries
Key secondary outcomes Sequential treatment regimens and overall survival (OS)

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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who were defined as unersectable (UR-) and were ineligible for these two studies by HOPS central MDCT review.
2) Pathologically or cytologically proven diagnosis of pancreas cancer.
3) Patients of age =>20
4) Performance Status:0-1 (ECOG)
5) Adequate oral intake
6) Good main organ function
Key exclusion criteria Patients who were defined as resectable (R-) or borderline resectable (BR-) by HOPS central MDCT review.
Target sample size 66

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasutoshi Kimura
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Email kimuray@sapmed.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yasutoshi Kimura
Organization Sapporo Medical University
Division name Department of Surgery, Surgical Oncology and Science
Zip code
Address S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL 011-611-2111
Homepage URL http://sapmed-surg1.jp/gairai/optout.shtml
Email kimuray@sapmed.ac.jp

Sponsor
Institute Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Institute
Department

Funding Source
Organization Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 05 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
2016 Year 05 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 06 Month 13 Day
Last follow-up date
2018 Year 04 Month 28 Day
Date of closure to data entry
2018 Year 05 Month 26 Day
Date trial data considered complete
2018 Year 05 Month 29 Day
Date analysis concluded
2019 Year 01 Month 31 Day

Other
Other related information Background information: age, sex, medical history,
Non-surgical treatment information: treatment, drug used, treatment period, treatment effect judgment
Surgical information: operative method, operation time, amount of bleeding
Postoperative information: postoperative complication, postoperative hospital stay
Information on postoperative information: presence or absence of postoperative adjuvant chemotherapy (drug, duration) Presence or absence of recurrence (presence or absence of treatment, content, duration), presence / absence of death, cause of death

Management information
Registered date
2019 Year 01 Month 05 Day
Last modified on
2019 Year 01 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040393

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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