UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030034 |
|---|---|
| Receipt number | R000034297 |
| Scientific Title | Genome Analysis on Lymph-related Diseases |
| Date of disclosure of the study information | 2017/11/20 |
| Last modified on | 2021/05/27 09:03:26 |
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Basic information
Public title
Genome Analysis on Lymph-related Diseases
Acronym
Genome Analysis on Lymph-related Diseases
Scientific Title
Genome Analysis on Lymph-related Diseases
Scientific Title:Acronym
Genome Analysis on Lymph-related Diseases
Region
| Japan |
Condition
Condition
Lymph-related diseases
Classification by specialty
| Medicine in general | Surgery in general | Plastic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to promote a genome analysis on lymph-related diseases and to introduce its achievements into clinical situations.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference of biomarkers which can reflect the targeted oetiology amongst the case and the control groups
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
blood taking
Interventions/Control_2
Surgery (only on the subjects who require operations in the patients group)
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
patients with lymph-related disease who are treated at Center Hospital of National Center for Global Medicine and Health
patients with written informed consent
Key exclusion criteria
Disorder of consciousness
Lacking of competency to consent
Severe anaemia (Hb < 8.0g/dL)
Considered not eligible for this study by the researchers
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | amamoto |
Organization
Center Hospital of National Center for Global Health and Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
tyamamoto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Yamamoto |
Organization
Center Hospital of National Center for Global Health and Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
162-8655
Address
1-21-1 Toyama Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
tyamamoto-tky@umin.ac.jp
Sponsor or person
Institute
Center Hospital of National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
National Center for Global Health and Medicine
Address
Toyama 1-21-1, Shinjuku-ku, Tokyo, Japan
Tel
0332027181
tyamamoto-tky@umin.ac.jp
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 | 11 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 20 | Day |
Last modified on
| 2021 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034297
