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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020575
Receipt No. 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

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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
Institute Okayama University Hospital
Institute
Department

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
URL(English) https://upload.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


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