UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047040 |
|---|---|
| Receipt number | R000053476 |
| Scientific Title | A relationship between cold hypersensitivity and genetic polymorphism: an exploratory observational study |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/02/16 14:40:01 |
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Basic information
Public title
A relationship between cold hypersensitivity and genetic polymorphism: an exploratory observational study
Acronym
A relationship between cold hypersensitivity and genetic polymorphism: an exploratory observational study
Scientific Title
A relationship between cold hypersensitivity and genetic polymorphism: an exploratory observational study
Scientific Title:Acronym
A relationship between cold hypersensitivity and genetic polymorphism: an exploratory observational study
Region
| Japan |
Condition
Condition
cold hypersensitivity
Classification by specialty
| Medicine in general | Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will search for statistically significant associations between subjective symptoms of cold hypersensitivity and genetic factors. In addition, we will compare the obtained data and interpret the results biologically to analogize the physiological mechanism of cold hypersensitivity.
Basic objectives2
Others
Basic objectives -Others
Although it has been suggested that cold hypersensitivity may be caused by genetic background, there are few reports on genetic analysis related to cold hypersensitivity, and the influence of genetic factors on cold hypersensitivity is not clear. In this study, we conduct a questionnaire survey of adult female volunteers (aged between 20 and 60 years) who had received the MYCODE genetic testing service (hereafter referred to as MYCODE) conducted by DeNA Life Sciences, Inc. We will explore the association between subjective symptoms of cold hypersensitivity and genetic polymorphism centered on SNPs (Single Nucleotide Polymorphism).
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Association of genetic polymorphism with subjective symptoms of cold hypersensitivity
Key secondary outcomes
Association of genetic polymorphism with site and burden of subjective symptoms of cold hypersensitivity
Association of physical symptom burden to presence/absence, site, and burden of subjective symptomatic cold hypersensitivity
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
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
1. Those who have given written consent to participate in the research to be conducted using the samples and information obtained through MYCODE (research title: "Research aimed at realizing a healthy and long-lived society using health big data") (in order to obtain and implement appropriate consent for those who have given comprehensive research consent to participate in this research)
2. Those who have MYCODE test results available at the time of consent (for use of information already available)
3. Adult females between 20 and 60 years of age (for selection of the target population)
4. Persons whose consent has been obtained (for obtaining appropriate consent)
Key exclusion criteria
1. Those who are currently diagnosed with heart failure, abnormal thyroid function (hyperthyroidism, hypothyroidism, chronic thyroiditis, or Hashimoto's disease), or malignancy (to potentially affect the evaluation)
2. Those who are currently hospitalized (as this may affect the evaluation)
3. Those who are currently pregnant or may become pregnant (as this may affect the evaluation).
4. Those who are judged to be excluded by the researcher (because it may affect the evaluation)
Target sample size
1200
Research contact person
Name of lead principal investigator
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University
Division name
Holistic Kampo Diagnosis Lab., Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
03-5366-3824
tetta213@keio.jp
Public contact
Name of contact person
| 1st name | Tetsuhiro |
| Middle name | |
| Last name | Yoshino |
Organization
Keio University
Division name
Holistic Kampo Diagnosis Lab., Keio University School of Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
TEL
0353663824
Homepage URL
tetta213@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
TSUMURA & CO.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
DeNA Life Science Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University Graduate School of Medicine
Address
35 Shinanomachi, Shinjuku, Tokyo, JAPAN
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
慶應義塾大学医学部漢方医学センター（東京都）、株式会社ツムラ（東京都）、株式会社DeNAライフサイエンス（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr/ctr_view_reg.cgi?recptno=R000053476
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1038/s41598-024-52119-y
Number of participants that the trial has enrolled
1200
Results
Among the 1111 participants, 599 reported cold hypersensitivity. Higher cold hypersensitivity severity was positively associated with the SSS-8 scores. A GWAS for cold hypersensitivity was conducted using array-based genomic data obtained from genetic testing. We identified 11 lead variants showing suggestive associations (P < 0.00001) with cold hypersensitivity, some of which showed a reasonable change in expression in specific tissues in the GTEx database.
Results date posted
| 2024 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 22 | Day |
Baseline Characteristics
1200 Japanese adult female volunteers (age: 20 to 59 years), recruited between April 21 and May 25, 2022, who were customers of MYCODE, a personal genome service in Japan.
Participant flow
A total of 1200 subjects were enrolled in the study, of whom 1111 met the inclusion criteria.
Adverse events
None
Outcome measures
Among the 1111 participants, 599 (54%) reported cold hypersensitivity. Higher cold hypersensitivity severity was positively associated with the SSS-8 scores. Additionally, a genome-wide association study for cold hypersensitivity was conducted using array-based genomic data obtained from genetic testing. We identified 11 lead variants showing suggestive associations (P < 0.00001 ) with cold hypersensitivity, some of which showed a reasonable change in expression in specific tissues in the Genotype-Tissue Expression database.
Plan to share IPD
N/A
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
The MYCODE customers who have given comprehensive research consent to have their genetic/health-related data used for research purposes are invited to participate in this study by an email informing its overview. Participants who provide online consent for participation are asked to answer an online questionnaire including information on attributes such as age, height, weight, current medical history, and symptoms of cold hypersensitivity. The answer data as well as genetic data already obtained by MYCODE will be anonymized and then used to analyze the relationship between genetic polymorphism and cold hypersensitivity. Under the overall management of Keio University, DeNA Life Science Inc. will conduct genetic analysis and Keio University will conduct questionnaire-to-questionnaire analysis on cold hypersensitivity and burden of physical symptoms based on an assessment protocol predetermined by TSUMURA & CO.
Management information
Registered date
| 2022 | Year | 03 | Month | 01 | Day |
Last modified on
| 2024 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053476
