UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027006 |
|---|---|
| Receipt number | R000030966 |
| Scientific Title | Genetic factor analysis of chemical sensitivity |
| Date of disclosure of the study information | 2017/04/21 |
| Last modified on | 2023/01/24 11:36:19 |
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Basic information
Public title
Genetic factor analysis of chemical sensitivity
Acronym
GFACS
Scientific Title
Genetic factor analysis of chemical sensitivity
Scientific Title:Acronym
GFACS
Region
| Japan |
Condition
Condition
Multiple Chemical Sensitivity/Idiopathic Environmental Intolerance
Classification by specialty
| Pneumology | Neurology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the genetic factor for multiple chemical sensitivity.
Basic objectives2
Others
Basic objectives -Others
To clarify the genetic factor for multiple chemical sensitivity by comparison of single nucleotide polymorphism between controls and the patients with multiple chemical sensitivity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of single nucleotide polymorphism between control and the patients with multiple chemical sensitivity.P value is less than 5X10^-8.
Key secondary outcomes
P value from 5X10^-8 to 1X10^-5 is highly suggestive association,
P value from 1X10^-5 to 1X10^-4 is moderately suggestive association.
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. To meet the 1999 consensus of Multiple Chemical Sensitivity.
2. 20 years of age and older
3. first-person informed consent
Key exclusion criteria
1. Comorbid with mastocytoma or porphyria
2. Only due to psychogenic disorder
3. Comorbid with severe asthma to prevent the diagnosis of multiple chemical sensitivity
4. Adverse event related to blood sampling in the past
5. The patients judged as unsuitable for participation by the researcher
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masami Taniguchi |
Organization
Clinical Research Center for Allergy and Rheumatology Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
m-taniguchi@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Watai |
Organization
Clinical Research Center for Allergy and Rheumatology Sagamihara National Hospital
Division name
Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1 Sakuradai Minami-ku Sagamihara Kanagawa Japan
TEL
042-742-8311
Homepage URL
k-watai@sagamihara-hosp.gr.jp
Sponsor or person
Institute
Clinical Research Center for Allergy and Rheumatology Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Clinical Research Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 04 | Month | 21 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
height, weight, gender, onset age, disease duration, the history of chemical exposures, family history,birth history, comorbid disease, QEESI questionnaire
Management information
Registered date
| 2017 | Year | 04 | Month | 16 | Day |
Last modified on
| 2023 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030966
| Research Plan | |
|---|---|
| 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 |
