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
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
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
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
