UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025087
Receipt number R000028620
Scientific Title The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas
Date of disclosure of the study information 2016/12/01
Last modified on 2024/01/06 07:37:33

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Basic information

Public title

The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas

Acronym

The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas

Scientific Title

The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas

Scientific Title:Acronym

The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas

Region

Japan


Condition

Condition

Solid-pseudopapillary neoplasm of the pancreas

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To identify the molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas.

Basic objectives2

Others

Basic objectives -Others

To identify the relationship between characteristic in molecular biology and clinicopathological findings

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas

Key secondary outcomes

The relationship between characteristic in molecular biology and clinicopathological findings


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

The patient with histologically confirmed diagnosis of Solid-pseudopapillary neoplasm

Key exclusion criteria

When the patient or his/her family refused to participate in this study

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Sakamoto

Organization

Kyorin University,School of Medicine

Division name

Department of Surgery

Zip code

181-8611

Address

6-20-2,Shinkawa,Mitaka-shi,Tokyo,181-8611,Japan

TEL

0422-47-5511

Email

yosakamo@ks.kyorin-u.ac.jp


Public contact

Name of contact person

1st name Kazuna
Middle name
Last name Honda

Organization

Kyorin University,School of Medicine

Division name

Department of Surgery

Zip code

181-8611

Address

6-20-2,Shinkawa,Mitaka-shi,Tokyo,181-8611,Japan

TEL

0422-47-5511

Homepage URL


Email

khonda@ks.kyorin-u.ac.jp


Sponsor or person

Institute

Kyorin University,School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyorin University,School of Medicine

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

Kyorin University School of Medicine

Address

6-20-2,Shinkawa,Mitaka-shi,Tokyo,181-8611,Japan

Tel

0422-47-5511

Email

irb@ks.kyorin-u.ac.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



Other administrative information

Date of disclosure of the study information

2016 Year 12 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

No longer recruiting

Date of protocol fixation

2016 Year 07 Month 06 Day

Date of IRB

2016 Year 07 Month 06 Day

Anticipated trial start date

2016 Year 12 Month 20 Day

Last follow-up date

2024 Year 07 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2021 Year 12 Month 31 Day


Other

Other related information

We identify the molecular biological characteristic of Solid-pseudopapillary neoplasm of the pancreas.


Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2024 Year 01 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028620


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name