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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041261
Receipt No. R000047118
Scientific Title A prospective study of the usefulness of circulating tumor DNA (ctDNA) as biomarker for the pancreatic cancer
Date of disclosure of the study information 2020/07/30
Last modified on 2020/07/30

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Basic information
Public title A prospective study of the usefulness of circulating tumor DNA (ctDNA) as biomarker for the pancreatic cancer
Acronym A prospective study of the usefulness of circulating tumor DNA (ctDNA) as biomarker for the pancreatic cancer
Scientific Title A prospective study of the usefulness of circulating tumor DNA (ctDNA) as biomarker for the pancreatic cancer
Scientific Title:Acronym A prospective study of the usefulness of circulating tumor DNA (ctDNA) as biomarker for the pancreatic cancer
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose is to determine the efficacy of the treatment of pancreatic cancer by measuring ctDNA.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The correlation of the dose of ctDNA during treatment and the survival.
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
80 years-old >
Gender Male and Female
Key inclusion criteria The patients are planned to treat according to our protocol for the treatment of pancreatic cancer.
Key exclusion criteria The patients follow our standard treatment protocol of pancreatic cancer.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Yamaue
Organization Wakayama medical university
Division name 2nd department of surgery
Zip code 641-8509
Address 811-1 Kimiidera Wakayama, Japan
TEL 073-441-0613
Email Yuji-kh@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Kitahata
Organization 2nd department of surgery, Wakayama medical university
Division name 2nd department of surgery
Zip code 641-8509
Address 811-1 Kimiidera Wakayama, Japan
TEL 073-441-0613
Homepage URL
Email Yuji-kh@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university
Institute
Department

Funding Source
Organization Research expense
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Wakayama medical university
Address 811-1 Kimiidera Wakayama, Japan
Tel 073-441-0613
Email wa-rinri@wakayama-med.ac.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
2020 Year 07 Month 30 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
2020 Year 03 Month 30 Day
Date of IRB
2020 Year 04 Month 27 Day
Anticipated trial start date
2020 Year 04 Month 27 Day
Last follow-up date
2023 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing

Management information
Registered date
2020 Year 07 Month 30 Day
Last modified on
2020 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047118

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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