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

Acoustic neuroma

Classification by specialty

Neurosurgery

Classification by malignancy

Others

Genomic information

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 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

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name