UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017989 |
|---|---|
| Receipt number | R000020848 |
| Scientific Title | A prospective study of the hearing disorder in the patient receiving cisplatin |
| Date of disclosure of the study information | 2015/06/20 |
| Last modified on | 2019/02/13 12:58:27 |
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Basic information
Public title
A prospective study of the hearing disorder in the patient receiving cisplatin
Acronym
Cisplatin hearing disorder study
Scientific Title
A prospective study of the hearing disorder in the patient receiving cisplatin
Scientific Title:Acronym
Cisplatin hearing disorder study
Region
| Japan |
Condition
Condition
Malignant tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe appearance time, frequency, degree of the hearing disorder receiving high dose cisplatin
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of hearing disorder more than CTCAE Grade2
Key secondary outcomes
Toxicity, dose intensity of cisplatin, change of the mean hearing threshold level
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
To give high dose cisplatin
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) Malignant tumor patient who will give more than 60 mg/m2 cisplatin
2) The patient who is evaluable in standard pure tone audiometry
3) Adult patient aged over 20 years
4) The patient that a document agreement by the free will after having received enough explanation on participating of this study
Key exclusion criteria
1) The patient that periodical audiometry is impossible
2) Patient younger than 20 years
3) The patient who judged a study doctor to be inappropriate as a subject
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Okada |
Organization
Kobe minimally invasive cancer center
Division name
Medical oncology
Zip code
Address
8-5-1, Minatojimanakamachi, Chuo-ku, Kobe-shi, Hyogo
TEL
078-304-4100
shumei_oka@joy.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Okada |
Organization
Kobe minimally invasive cancer center
Division name
Medical oncology
Zip code
Address
8-5-1, Minatojimanakamachi, Chuo-ku, Kobe-shi, Hyogo
TEL
078-304-4100
Homepage URL
shumei_oka@joy.ocn.ne.jp
Sponsor or person
Institute
Kobe minimally invasive cancer center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
| 2015 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020848
