UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049660 |
|---|---|
| Receipt number | R000056561 |
| Scientific Title | Characteristics of skin color in Japanese healthy subjects and patients with cardiac or pulmonary disease: influence of blood pressure and hemoglobin concentration on skin color |
| Date of disclosure of the study information | 2022/12/06 |
| Last modified on | 2023/01/21 13:49:17 |
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Basic information
Public title
Characteristics of skin color in Japanese healthy subjects and patients with cardiac or pulmonary disease: influence of blood pressure and hemoglobin concentration on skin color
Acronym
Characteristics of skin color in Japanese healthy subjects and patients with cardiac or pulmonary disease: influence of blood pressure and hemoglobin concentration on skin color
Scientific Title
Characteristics of skin color in Japanese healthy subjects and patients with cardiac or pulmonary disease: influence of blood pressure and hemoglobin concentration on skin color
Scientific Title:Acronym
Characteristics of skin color in Japanese healthy subjects and patients with cardiac or pulmonary disease: influence of blood pressure and hemoglobin concentration on skin color
Region
| Japan |
Condition
Condition
Healthy, hypertension, COPD, interstitial pneumonia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify skin color in healthy subjects and patients with chronic cardiopulmonary disease using a spectrophotometer and to examine the relationship between skin color and blood pressure, hemoglobin concentration, and oxygen saturation.
Basic objectives2
Others
Basic objectives -Others
Epidemiological Study of Skin Color in the Japanese
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin color (L*a*b*) in the forehead and forearm
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. Japanese
2. 20 years-old<=
3. Person who takes blood exam. on the measured day
4. Stable underlying disease (for example, hypertension)
5. Persons who have been fully informed and have given written consent of their own free will
Key exclusion criteria
1. Skin lesions (rash, trauma, scarring, etc.) at the measurement site (forehead, forearms).
2. Diseases that cause pigmentation (hyperthyroidism, liver cirrhosis, chronic renal failure, etc.)
3. Inability to remain at rest during skin color measurement
4. Persons deemed inappropriate by the principal investigator/assigned investigator
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine, Faculty of Nursing
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
tkutsu@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kutsuzawa |
Organization
Tokai University
Division name
School of Medicine, Faculty of Nursing
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa
TEL
0463-93-1121
Homepage URL
tkutsu@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai 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
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shiomkasuya, Isehara, Kanagawa
Tel
0463-93-1121
tokai-rinsho@ml.tokai-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
東海大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Skin color is measured on the day of the health checkup or outpatient visit (with blood sampling at the clinic).
The relationship with vital signs and blood sampling data at the time of measurement will be investigated.
Management information
Registered date
| 2022 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056561
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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