UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023213
Receipt number R000026620
Scientific Title A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size
Date of disclosure of the study information 2016/07/19
Last modified on 2019/07/22 19:27:10

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Basic information

Public title

A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size

Acronym

A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size

Scientific Title

A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size

Scientific Title:Acronym

A prospective multicenter cohort study in patients with pancreatic cysts less than 10 mm in size

Region

Japan


Condition

Condition

Pancreatic cysts less than 10 mm in size

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)

Basic objectives2

Others

Basic objectives -Others

To elucidate the natural history of pancreatic cysts less than 10 mm in size

Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of occurrences of pancreatic ductal adenocarcinoma (PDAC)

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with pancreatic cysts less than 10 mm in size on MRI

Key exclusion criteria

1) Patients with pancreatic cysts 10 mm or more in size
2) Patients with pancreatic cysts less than 10 mm in size concomitant with pancreatic cysts 10 mm or more in size
3) A concurrence of pancreatic malignancies at the time of registration
5) Patients from whom informed consent cannot be obtained
6) Patients who are judged inappropriate for the participation for this study by attending doctors

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Satoshi
Middle name
Last name Tanno

Organization

IMS Sapporo Digestive Disease Center General Hospital

Division name

Department of Gastroenterology

Zip code

063-0842

Address

1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo

TEL

011-611-1391

Email

satoshtanno@gmail.com


Public contact

Name of contact person

1st name Satoshi
Middle name
Last name Tanno

Organization

IMS Sapporo Digestive Disease Center General Hospital

Division name

Department of Gastroenterology

Zip code

063-0842

Address

1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo

TEL

011-611-1391

Homepage URL


Email

satoshtanno@gmail.com


Sponsor or person

Institute

Japan Pancreas Society

Institute

Department

Personal name



Funding Source

Organization

Japan Pancreas Society

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

IMS Sapporo Digestive Disease Center General Hospital

Address

1-1-1, Hachiken-nijou-nishi, Nishi-ku, Sapporo

Tel

011-611-1391

Email

satoshtanno@gmail.com


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

2016 Year 07 Month 19 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

1131

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

No longer recruiting

Date of protocol fixation

2016 Year 06 Month 30 Day

Date of IRB

2016 Year 06 Month 16 Day

Anticipated trial start date

2016 Year 07 Month 01 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

A multicenter prospective cohort study


Management information

Registered date

2016 Year 07 Month 18 Day

Last modified on

2019 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name