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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027006
Receipt No. R000030966
Scientific Title Genetic factor analysis of chemical sensitivity
Date of disclosure of the study information 2017/04/21
Last modified on 2018/04/23

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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
Email 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
Email k-watai@sagamihara-hosp.gr.jp

Sponsor
Institute Clinical Research Center for Allergy and Rheumatology Sagamihara National Hospital
Institute
Department

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
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

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 Open public recruiting
Date of protocol fixation
2016 Year 11 Month 05 Day
Date of IRB
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
2018 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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