UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035688 |
|---|---|
| Receipt number | R000040652 |
| Scientific Title | The association of blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue |
| Date of disclosure of the study information | 2019/01/27 |
| Last modified on | 2025/02/06 18:58:37 |
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Basic information
Public title
The association of blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue
Acronym
The association of blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue
Scientific Title
The association of blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue
Scientific Title:Acronym
The association of blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the correlation between blood pressure and renin - angiotensin - aldosterone system (RAAS) in the human skin tissue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association of renin - angiotensin - aldosterone system (RAAS) in the human skin tissue and blood pressure
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients over 20 years of age
(2) Patients with Stage 1-3 rectal cancer who scheduled to have a stoma making
(3) Patients who have consent to hospitalization for participation in this study
Key exclusion criteria
(1) Patients with infection
(2) Patients with steroid or immunosuppressant
(3) Patients with sick skin disease (atopic dermatitis, psoriasis etc)
(4) Patients who are judged by an investigator to be inappropriate for this study for any other reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Graduate school of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
ryukoba@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Kobayashi |
Organization
Yokohama City University Graduate school of Medicine
Division name
Department of Medical Science and Cardiorenal Medicine
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
045-787-2800
Homepage URL
ryukoba@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama City University Medical Center
Department of Pharmacology, Kagawa University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
Tel
045-787-2714
rinri@yokohama-cu.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
横浜市立大学附属病院(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 27 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 30 | Day |
Other
Other related information
Angiotensin II and Angiotensinogen levels
Management information
Registered date
| 2019 | Year | 01 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040652
