UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028660 |
|---|---|
| Receipt number | R000032807 |
| Scientific Title | Validation of novel combinations of serum microRNAs for detecting cancers |
| Date of disclosure of the study information | 2017/08/15 |
| Last modified on | 2017/08/14 20:08:32 |
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Basic information
Public title
Validation of novel combinations of serum microRNAs for detecting cancers
Acronym
Detecting cancers by serum microRNAs
Scientific Title
Validation of novel combinations of serum microRNAs for detecting cancers
Scientific Title:Acronym
Detecting cancers by serum microRNAs
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation of the combinations of serum microRNAs to detect cancers by using prospectively collected blood samples
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate of diagnosis by using the combinations of serum microRNAs
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who diagnosed and will be treated at National Cancer Center
2. Healthy volunteer
3. Written informed consent
Key exclusion criteria
no exclusion criteria
Target sample size
3440
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Ochiya, Ph.D |
Organization
National Cancer Center Research Institute
Division name
Div. of Molecular and Cellular Medicine
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
tochiya@ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Shimomura, M.D. |
Organization
National Cancer Center Hospital
Division name
Dept. of Breast and Medical Oncology
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
03-3542-2511
Homepage URL
ashimomu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 08 | 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
none
Management information
Registered date
| 2017 | Year | 08 | Month | 14 | Day |
Last modified on
| 2017 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032807
