UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease
Acronym	Examination of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease
Scientific Title	Examination of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease
Scientific Title:Acronym	Examination of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease
Region	Japan

Condition
Condition	Malignant biliary stricture
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the efficacy of the cancer genomic profiling test using bile cell block specimens and bile cytology specimens in malignant biliary tract disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Success rate and accuracy of cancer gene analysis using bile samples
Key secondary outcomes	Quantity and quality of DNA The relationship between cancer gene analysis and anticancer drug Factors for accurate cancer gene analysis

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	20 years-old <=
Age-upper limit	120 years-old >=
Gender	Male and Female
Key inclusion criteria	Age > 19 years The patients who was able to place ENBD or PTBD, and collect bile for cytology and cell block method The case with written informed consent for participation
Key exclusion criteria	The patients who was not able to place ENBD or PTBD The patients who were already diagnosed cytologically or histologically before this study The patients who are otherwise judged by the investigator to be ineligible to participate in the study
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Mitsuru Middle name Last name Okuno
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Zip code	500-8513
Address	7-1 Kasima-cho, Gifu city, Gifu
TEL	058-251-1101
Email	mkobdkl@yahoo.co.jp

Public contact
Name of contact person	1st name Mitsuru Middle name Last name Okuno
Organization	Gifu Municipal Hospital
Division name	Department of Gastroenterology
Zip code	500-8513
Address	7-1 Kasima-cho, Gifu city, Gifu
TEL	058-251-1101
Homepage URL
Email	mkobdkl@yahoo.co.jp

Sponsor
Institute	Gifu Municipal Hospital
Institute
Department

Funding Source
Organization	none
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	Gifu Municipal Hospital
Address	7-1 Kasima-cho, Gifu city, Gifu
Tel	058-251-1101
Email	mkobdkl@yahoo.co.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	2022 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	Open public recruiting
Date of protocol fixation	2022 Year 09 Month 15 Day
Date of IRB	2022 Year 09 Month 15 Day
Anticipated trial start date	2022 Year 11 Month 25 Day
Last follow-up date	2027 Year 11 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 11 Month 26 Day
Last modified on	2022 Year 11 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056508