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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034022
Receipt No. R000038787
Scientific Title Prospective study to identify prognostic markers of pancreatic cancer
Date of disclosure of the study information 2018/11/01
Last modified on 2018/10/31

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Basic information
Public title Prospective study to identify prognostic markers of pancreatic cancer
Acronym Identification of preoperative and postoperative prognostic markers of pancreatic cancer
Scientific Title Prospective study to identify prognostic markers of pancreatic cancer
Scientific Title:Acronym Identification of preoperative and postoperative prognostic markers of 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 The aim of this study was to investigate the use of the preoperative and postoperative prognostic factors as useful markers for the poor prognosis of pancreatic cancer patients.
Basic objectives2 Others
Basic objectives -Others To determine whether the prognostic factors are useful to predict the prognosis of pancreatic cancer patients
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

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
90 years-old >
Gender Male and Female
Key inclusion criteria (1) more than 20 years old and less than 90 years old
(2) pancreatic cancer patients newly diagnosed and previously untreated
(3) surgically-adapted pancreatic cancer patients
Key exclusion criteria (1) pancreatic cancer patients previously treated
(2) non-surgically-adapted pancreatic cancer patients
(3) patients who were suffering from any kind of malignancies including pancreatic cancer within 5 years
(4) sever renal or liver dysfunction
(5) individuals who did not accept informed consent
(6) unsuitable individuals for this clinical study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Taniuchi
Organization Kochi Medical School Hospital, Kochi University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi
TEL 088-880-2338
Email ktaniuchi@kochi-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Taniuchi
Organization Kochi Medical School Hospital, Kochi University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Kohasu, Oko-cho, Nankoku, Kochi
TEL 088-880-2338
Homepage URL
Email ktaniuchi@kochi-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Kochi Medical School Hospital, Kochi University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Kanagawa Cancer Center
Tokyo Metropolitan Tama Medical Center
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
2018 Year 11 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 31 Day
Last follow-up date
2025 Year 06 Month 30 Day
Date of closure to data entry
2025 Year 07 Month 31 Day
Date trial data considered complete
2025 Year 09 Month 30 Day
Date analysis concluded
2025 Year 12 Month 31 Day

Other
Other related information This study was approved by the ethical review boards of Kochi Medical School, Kanagawa Cancer Center and Tokyo Metropolitan Tama Medical Center prior to patient recruitment. Written informed consent was acquired from each patient prior to initiation.

Management information
Registered date
2018 Year 09 Month 04 Day
Last modified on
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038787

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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