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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044430
Receipt No. R000050755
Scientific Title Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Date of disclosure of the study information 2021/06/04
Last modified on 2021/06/04

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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

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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