UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013335
Receipt number R000015563
Scientific Title Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors
Date of disclosure of the study information 2014/05/01
Last modified on 2014/03/04 22:23:17

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Basic information

Public title

Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors

Acronym

Retrospective analysis of patients with resectable pancreatic neuroendocrine tumors

Scientific Title

Retrospective analysis study on the prognosis of patients with resectable pancreatic neuroendocrine tumors

Scientific Title:Acronym

Retrospective analysis of patients with resectable pancreatic neuroendocrine tumors

Region

Japan


Condition

Condition

pancreatic neuroendocrine tumor

Classification by specialty

Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the factors related with the prognosis and relations the results of contrast enhanced computed tomography (CECT) and prognosis.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Compare the enhancement pattern of CECT and their malignant potential from pathological findings

Key secondary outcomes

1) Compare the enhancement pattern of CECT and detailed pathological findings
2) Relation between the enhancement pattern of CECT and prognosis


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

10 years-old <

Age-upper limit

99 years-old >=

Gender

Male and Female

Key inclusion criteria

The patients with resected pancreatic neuroendocrine tumors

Key exclusion criteria

unresectable cases

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuzo Kodama

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

Kawahara-cho54, Shogoin, Sakyopku, Kyoto, Japan

TEL

075-751-4319

Email

kodamayu@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Kurita

Organization

Kyoto University

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

Kawahara-cho54, Shogoin, Sakyopku, Kyoto, Japan

TEL

075-751-4319

Homepage URL


Email

akurita@kuhp.kyoto-u.ac.jp


Sponsor or person

Institute

Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Kyoto University

Organization

Division

Category of Funding Organization

Other

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

2014 Year 05 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

2014 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2014 Year 03 Month 05 Day

Last follow-up date

2014 Year 05 Month 31 Day

Date of closure to data entry

2014 Year 05 Month 31 Day

Date trial data considered complete

2014 Year 06 Month 30 Day

Date analysis concluded

2014 Year 12 Month 31 Day


Other

Other related information

retrospective study


Management information

Registered date

2014 Year 03 Month 04 Day

Last modified on

2014 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015563


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name