UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000520 |
|---|---|
| Receipt number | 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 14:05:10 |
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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)
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
Sponsor or person
Institute
Sectional committee for epidemiological studies, Committee of promotion for living body and electromagnetic environment research, Ministry of Internal Affairs and Communications
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000629
