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 2019/01/27 18:40:18

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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
Middle name
Last name Ryu Kobayashi

Organization

Yokohama City University Graduate school of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Email

ryukoba@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryu Kobayashi

Organization

Yokohama City University Graduate school of Medicine

Division name

Department of Medical Science and Cardiorenal Medicine

Zip code


Address

3-9, Fukuura, Kanazawa-ku, Yokohama

TEL

045-787-2800

Homepage URL


Email

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


Address


Tel


Email



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

2019 Year 01 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040652


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name