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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000520
Receipt No. R000000629
Scientific Title Nationwide research of relationship between health and cell phone usage - Case-only study on patients with acoustic neuroma
Date of disclosure of the study information 2006/11/11
Last modified on 2007/06/06

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Basic information
Public title Nationwide research of relationship between health and cell phone usage - Case-only study on patients with acoustic neuroma
Acronym Nationwide research of relationship between health and cell phone usage
Scientific Title Nationwide research of relationship between health and cell phone usage - Case-only study on patients with acoustic neuroma
Scientific Title:Acronym Nationwide research of relationship between health and cell phone usage
Region
Japan

Condition
Condition Acoustic neuroma
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This research aims to clarify the relation between cell phone use (ear used, right or left) and places of acoustic neuroma (right or left), and to check the safety of cell phones.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relation between cell phone use (ear used, right or left) and places of acoustic neuroma (right or left).
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with acoustic neuroma, whose first medical examination day was after January 1, 2000.
Cases whose tissue diagnosis or image diagnosis was used.
Cases whose names of the diseases were informed to the patients.
Cases whose informed consent is obtained.
Key exclusion criteria Those who deceased are excluded.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naohito Yamaguchi
Organization Tokyo Women's Medical University
Division name Hygiene and public health II
Zip code
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo
TEL 03-3353-8111(ext.22121)
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuto Sato
Organization Tokyo Women's Medical University
Division name Hygiene and public health II
Zip code
Address 8-1 Kawada-cho Shinjuku-ku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Sectional committee for epidemiological studies, Committee of promotion for living body and electromagnetic environment research, Ministry of Internal Affairs and Communications
Institute
Department

Funding Source
Organization Ministry of Internal Affairs and Communications
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2006 Year 11 Month 11 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
2005 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 04 Month 01 Day
Date analysis concluded
2007 Year 06 Month 01 Day

Other
Other related information Questions in the questionnaire are as follows:
Date when the patient was diagnosed as acoustic neruroma for the first time.
Subjective symptom of the disease when diagnosed.
Period of cell phone usage.
Telephone call frequency, average call duration, ear used when they began to use cell phones.
Whether or not they changed the ear that they use for cell phone call.
Usage of hands-free devices.
Subjective symptom of the disease, Telephone call frequency, Call duration, Ear used one year before the diagnosis.
Subjective symptom of the disease, Telephone call frequency, Call duration, Ear used, five years before the diagnosis.
Dominant hand

Clinical information collected is as follows:
Sex
Date of birth
First medical examination day
Initial symptom; Dizziness
Initial symptom; Tinnitus
Initial symptom; Hard hearing
Case history
Place
Size
Diagnosis grounds
Treatment
Operation day
Histological type

Management information
Registered date
2006 Year 11 Month 11 Day
Last modified on
2007 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000629

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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