UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020575
Receipt number R000023756
Scientific Title A prospective study of the clinical utility of immunocytochemistry in liquid-based cytology for pancreatic tumors
Date of disclosure of the study information 2016/01/15
Last modified on 2016/01/21 13:01:23

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Basic information

Public title

A prospective study of the clinical utility of immunocytochemistry in liquid-based cytology for pancreatic tumors

Acronym

A prospective study of the clinical utility of ICC in LBC for pancreatic tumors

Scientific Title

A prospective study of the clinical utility of immunocytochemistry in liquid-based cytology for pancreatic tumors

Scientific Title:Acronym

A prospective study of the clinical utility of ICC in LBC for pancreatic tumors

Region

Japan


Condition

Condition

Pancreatic tumors

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the utility of immunocytochemistry in liquid-based cytology for pancreatic tumors

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The diagnostic accuracy of immunocytochemistry in liquid-based cytology for pancreatic tumors

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1, Informed consent is required from all patients or their family.
2, Patients of age =>16.
3, Patients with pancreatic tumor detected by imaging modalities

Key exclusion criteria

1, Patients with serious complication in other organ.
2, Patients who have risk of bleeding.
3, Patients with pancreatic tumor which we cannot detect or puncture by EUS.
4, Patients with performance status 4.
5, Inappropriate patients for entry on this study in the judgement of the investigator.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironari Kato

Organization

Okayama University Hospital

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

2-5-1 Shikata-cho,Kita-ku, Okayama-city, Okayama

TEL

086-235-7219

Email

drkatocha@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yutaka Akimoto

Organization

Okayama University Hospital

Division name

Department of Gastroenterology & Hepatology

Zip code


Address

2-5-1 Shikata-cho,Kita-ku, Okayama-city, Okayama

TEL

086-235-7219

Homepage URL


Email

qttsp974@gmail.com


Sponsor or person

Institute

Okayama University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okayama University Hospital

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


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

2016 Year 01 Month 15 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

Preinitiation

Date of protocol fixation

2016 Year 01 Month 14 Day

Date of IRB


Anticipated trial start date

2016 Year 02 Month 24 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Study design: Prospective observational study.
Study subjects: All patients with inclusion criteria in our collaborating institutions between February 2016 and March 2018.
Measurements: Pre- and Post-operative clinical and demographic characteristics including preoperative imaging. Results of immunostaining of LBC and histological specimen obtained by EUS-FNA. Results of final pathological diagnosis and immunostaining of resected specimen.


Management information

Registered date

2016 Year 01 Month 15 Day

Last modified on

2016 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023756


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name