UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017586 |
|---|---|
| Receipt number | 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 15:23:02 |
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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
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
emizu1214@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020311
