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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000017586
Receipt No. R000020311
Scientific Title The prospective study of absolute quantitation of KRAS mutaition in cell free plasma DNA with pancreatic ductal adenocarcinoma.
Date of disclosure of the study information 2015/05/15
Last modified on 2015/05/15

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Basic information
Public title The prospective study of absolute quantitation of KRAS mutaition in cell free plasma DNA with pancreatic ductal adenocarcinoma.
Acronym The analysis of mutated KRAS in patients with pancreatic ductal adenocarcinoma.
Scientific Title The prospective study of absolute quantitation of KRAS mutaition in cell free plasma DNA with pancreatic ductal adenocarcinoma.
Scientific Title:Acronym The analysis of mutated KRAS in patients with pancreatic ductal adenocarcinoma.
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Our objectives are absolute quantitation of cell free DNA and rare mutant KRAS alteration in plasma sample of patients with pancreatic cancer using droplet digital PCR (ddPCR) which is the new technology that more sensitive and more reproducible than real time PCR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of the detectable curculating tumor DNA for prognostic factor of pancreatic caner patients.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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)Subject who is histologically confirmed pancreatic cancer.
2)Subject whose agreement with signiture of aplicant has obtained before initiation of this study.
Key exclusion criteria 1)Subjects who have another malignancies simultaneously.
2)Subjects who is participating in another clinical trial affect to primary or secondary end-point of this study
3)Subjects whose Hb levels were less than 7 g/dL
4)Subject who is judged to be ineligible due to subject's background, physical findings, medical examination, physical and clinical examination by principal investigator or sub investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiaki Murakami
Organization Hiroshima University
Division name Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address Kasumi, Minami-Ku, Hiroshima, JAPAN
TEL 082-257-5215
Email emizu1214@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoto Hadano
Organization Hiroshima University
Division name Institute of Biomedical and Health Sciences Applied Life Sciences Surgery
Zip code
Address Kasumi, Minami-Ku, Hiroshima, JAPAN
TEL 082-257-5215
Homepage URL
Email emizu1214@yahoo.co.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization No
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
Address
Tel
Email

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
2015 Year 05 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 Open public recruiting
Date of protocol fixation
2013 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No

Management information
Registered date
2015 Year 05 Month 15 Day
Last modified on
2015 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020311

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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