UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044573 |
|---|---|
| Receipt number | R000050915 |
| Scientific Title | Exploring epigenetic anti-cancer agents from oriental traditional medicines and elucidation of their mechanism |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2021/06/17 11:53:59 |
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Basic information
Public title
Exploring epigenetic anti-cancer agents from oriental traditional medicines and elucidation of their mechanism
Acronym
Exploring epigenetic anti-cancer agents from oriental traditional medicines and elucidation of their mechanism
Scientific Title
Exploring epigenetic anti-cancer agents from oriental traditional medicines and elucidation of their mechanism
Scientific Title:Acronym
Exploring epigenetic anti-cancer agents from oriental traditional medicines and elucidation of their mechanism
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to search for antitumor agents with epigenome molecule targets from oriental traditional medicines through bioinformatic analyses and to construct a safe and clinically applicable cancer treatment strategy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Ex vivo cell proliferation assays are performed on peripheral blood mononuclear cells of healthy volunteers.
Key secondary outcomes
If necessary, using peripheral blood mononuclear cell samples treated with drugs, changes in gene expression, histone modification and open chromatin regions will be assesed by RNA-seq, ChIP-seq and ATAC-seq.
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) Age: 20 years and over
2) Agreement to a doctor's interview regarding health condition.
3) Systolic blood pressure is 90-160 mmHg and diastolic blood pressure is 100 mmHg or less
4) Weight: men 45 kg or more, women 40 kg or more
5) After receiving sufficient explanation for participation in this study, written consent by free will have been obtained with sufficient understanding
Key exclusion criteria
1) There is a disease that requires treatment, or the patient is under examination due to suspicion of the disease.
2) Have a history of blood disorders
3) History of blood transfusion or history of organ transplantation
4) Pregnant or within 1 year of delivery
5) History of the following infectious diseases
(A) Malaria, Toxoplasma
(B) Tuberculosis within 5 years after healing
(C) Sexually transmitted diseases within 1 year after healing
(D) Dengue fever within 1 month after healing
(E) Onset of erythema infectiosum in the person within 6 months after healing or onset in the family within 1 month
6) Anyone judged inappropriate by the doctor
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Hirasaki |
Organization
Graduate School of Medicine, Chiba university
Division name
Department of Japanese-Oriental (Kampo) Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2984
hrskyshr@chiba-u.jp
Public contact
Name of contact person
| 1st name | Yoshiro |
| Middle name | |
| Last name | Hirasaki |
Organization
Graduate School of Medicine, Chiba university
Division name
Department of Japanese-Oriental (Kampo) Medicine
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-226-2984
Homepage URL
hrskyshr@chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Department of Japanese-Oriental(Kampo) Medicine, Graduate School of Medicine, Chiba university
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
Tel
0432262984
hrskyshr@chiba-u.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
| 2021 | Year | 06 | Month | 25 | 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
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Ex vivo studies using blood samples collected from healthy volunteers
Management information
Registered date
| 2021 | Year | 06 | Month | 17 | Day |
Last modified on
| 2021 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050915
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
