UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039623
Receipt number R000045193
Scientific Title Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer
Date of disclosure of the study information 2020/03/01
Last modified on 2020/04/27 20:21:29

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Basic information

Public title

Evalutation of the patients with localized stricture of MPD without obvious mass in the pancreas

Acronym

Pancreatic cancer study

Scientific Title

Clinical study to detect the feature of imaging modalities for the early detection of pancreatic cancer

Scientific Title:Acronym

Study for the early detection of pancreatic cancer

Region

Japan


Condition

Condition

Patients with localized MPD stricture without obvious mass in pancreas

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to find new imaging findings leading to the early detection of pancreatic cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Reading computed tomography, magnetic resonance imaging, and endoscopic ultrasonography image.

Key secondary outcomes



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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with MPD stricture

Key exclusion criteria

Patients with obvious pancreatic mass
Patients with chronic pancreatitis
Patients with post pancreatic surgery
Patients with pancreatic injury

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Akira
Middle name
Last name Kurita

Organization

Kitano Hospital, Tazuke Kofukai Medical Research Institute.

Division name

Department of Gastroenterology and Hepatology

Zip code

530-8480

Address

2-4-20 Ohgimachi, Kita-ku, Osaka 530-8480, Japan.

TEL

06-6131-2662

Email

kuritaaki1976@gmail.com


Public contact

Name of contact person

1st name Akira
Middle name
Last name Kurita

Organization

Kitano Hospital, Tazuke Kofukai Medical Research Institute.

Division name

Department of Gastroenterology and Hepatology

Zip code

530-8480

Address

2-4-20 Ohgimachi, Kita-ku, Osaka, Japan

TEL

06-6131-2662

Homepage URL


Email

kuritaaki1976@gmail.com


Sponsor or person

Institute

Kitano Hospital, Tazuke Kofukai Medical Research Institute.

Institute

Department

Personal name



Funding Source

Organization

Kitano Hospital, Tazuke Kofukai Medical Research Institute.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Ethics Committee of Kitano Hospital

Address

2-4-20 Ohgimachi, Kita-ku, Osaka, Japan

Tel

06-6131-2662

Email

rinshou@kitano-hp.or.jp


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

公益財団法人田附興風会医学研究所北野病院


Other administrative information

Date of disclosure of the study information

2020 Year 03 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

Enrolling by invitation

Date of protocol fixation

2013 Year 01 Month 01 Day

Date of IRB

2018 Year 08 Month 01 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2020 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective analysis


Management information

Registered date

2020 Year 02 Month 28 Day

Last modified on

2020 Year 04 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045193


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name