UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014076 |
|---|---|
| Receipt number | R000016384 |
| Scientific Title | Developing Investigator-initiated Clinical Research protocol. |
| Date of disclosure of the study information | 2014/05/28 |
| Last modified on | 2017/11/27 15:44:58 |
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Basic information
Public title
Developing Investigator-initiated Clinical Research protocol.
Acronym
Developing Investigator-initiated Clinical Research protocol.
Scientific Title
Developing Investigator-initiated Clinical Research protocol.
Scientific Title:Acronym
Developing Investigator-initiated Clinical Research protocol.
Region
| Japan |
Condition
Condition
protocol
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The quality evaluation of investigator-initiated clinical trial protocols
Basic objectives2
Others
Basic objectives -Others
Developing how to improve protocol.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not specified
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. clinical trials consulter on the Tokyo women's hospital 2.not yet passed a review of the ethics committee 3. investigator-initiated clinical trial 4. receiving a full explanation Upon participation in the study, on a full understanding, the resulting document voluntary consent
Key exclusion criteria
1, clinical experience trial. 2, company initiated trial. 3, no consent 4, judged disqualification
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Aruga |
Organization
Joint Graduate School of Tokyo Women's Medical University and Waseda University
Division name
Cooperative Major in Advanced Biomedical Scienccces Institute of Advanced Biomedical Engineering and Science
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-5367-9945
aruga6638@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaya goto |
Organization
Joint Graduate School of Tokyo Women's Medical University and Waseda University
Division name
Cooperative Major in Advanced Biomedical Scienccces Institute of Advanced Biomedical Engineering and
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
09035540449
Homepage URL
masaya1984j_med@yahoo.co.jp
Sponsor or person
Institute
Joint Graduate School of Tokyo Women's Medical University and Waseda University
Institute
Department
Personal name
Funding Source
Organization
Joint Graduate School of Tokyo Women's Medical University and Waseda University
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 | 05 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 08 | Month | 31 | Day |
Other
Other related information
One year after consent
Management information
Registered date
| 2014 | Year | 05 | Month | 26 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016384
