UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034022
Receipt number 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 11:09:00

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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