UMIN-CTR Clinical Trial

Basic information
Public title	Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Acronym	Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Scientific Title	Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Scientific Title:Acronym	Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Region	Japan

Condition
Condition	Pancreatic cancer Biliary tract cancer
Classification by specialty	Medicine in general Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Analyze the expression of small RNAs associated with diagnostic, recurrence, and therapeutic effects in patients diagnosed with pancreatic cancer and biliary tract cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Small RNAs associated with diagnosis 2) Investigate the relationship between the following items and the expression status of small RNAs <Patient background> Patient age, gender, primary site, stage, treatment method and information on results and course, information on recurrence and metastasis, information on unfollowable or termination due to transfer, etc.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnosed or clinically suspected pancreatic cancer or biliary tract cancer patients. 2) Scheduled treatment at our hospital 3) The consent has been obtained 4) 20 years old and over
Key exclusion criteria	1) Have a history or complication of other cancers 2) Judged as lacking consent due to dementia or mental illness 3)Patients who have decided inappropriate to include in this study by the investigators
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naoto Middle name Last name Gotohda
Organization	National Cancer Center Hospital East
Division name	Department of Hepatobiliary and Pancreatic Surgery
Zip code	277-8577
Address	6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
TEL	04-7133-1111
Email	ngotohda@east.ncc.go.jp

Public contact
Name of contact person	1st name Morie Middle name Last name Nishiwaki
Organization	MiRTeL Co.Ltd.
Division name	Research and Development Division
Zip code	734-0001
Address	1-2-10 Deshio Minami-ku, Hiroshima city, Hiroshima, Japan
TEL	082-546-9797
Homepage URL
Email	kenkyu@mirtel.co.jp

Sponsor
Institute	MiRTeL Co.Ltd.
Institute
Department

Funding Source
Organization	MiRTeL Co.Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Hospital East
Address	6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
Tel	04-7133-1111
Email	irst@ml.res.ncc.go.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	2021 Year 06 Month 04 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	2021 Year 03 Month 22 Day
Date of IRB	2021 Year 05 Month 20 Day
Anticipated trial start date	2021 Year 06 Month 04 Day
Last follow-up date	2024 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1) Small RNAs related with diagnosis of malignancy 2) Relationship between the status of small RNAs and the following clinicopathological factors: age, sex, tumor site, stage, therapy, clinical course, recurrence, metastasis, and survival

Management information
Registered date	2021 Year 06 Month 04 Day
Last modified on	2021 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050755