UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014691 |
|---|---|
| Receipt number | R000016870 |
| Scientific Title | Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers. |
| Date of disclosure of the study information | 2014/07/30 |
| Last modified on | 2021/09/01 17:29:21 |
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Basic information
Public title
Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Acronym
Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Scientific Title
Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Scientific Title:Acronym
Analysis of cell-free nucleic acids in the blood as biomarkers for diagnosis and therapy-evaluation of pancreatic, biliary and liver cancers.
Region
| Japan |
Condition
Condition
Patients diagnosed or suspected as liver cancer, pancreatic cancer and biliary cancer
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect cell-free nucleic acids in the blood from patients with malignancy and investigate its efficacy as biomarkers for screening, therapy evaluation and prognostic prediction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the clinical utility of cell-free nucleic acids in the blood.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who diagnosed or suspected as liver cancer, pancreatic cancer and biliary cancer
Key exclusion criteria
Patients without informed consent.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
03-5363-3802
contact@keio-hpbts.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minoru Kitago |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
Shinanomachi 35, Shinnjuku-ku, Tokyo 160-8582
TEL
03-5363-3802
Homepage URL
contact@keio-hpbts.jp
Sponsor or person
Institute
Department of Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | 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
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No aprreciable matter.
Management information
Registered date
| 2014 | Year | 07 | Month | 28 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016870
