UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004305 |
|---|---|
| Receipt number | R000005159 |
| Scientific Title | Evaluation for neurotoxicity of oxaliplatin using Nerve Conduction Velocity |
| Date of disclosure of the study information | 2010/09/30 |
| Last modified on | 2013/04/02 21:23:23 |
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Basic information
Public title
Evaluation for neurotoxicity of oxaliplatin using Nerve Conduction Velocity
Acronym
NEO-NCV study
Scientific Title
Evaluation for neurotoxicity of oxaliplatin using Nerve Conduction Velocity
Scientific Title:Acronym
NEO-NCV study
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastroenterology | Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the utility of nerve conduction velocity (NCV) and tuning fork for the oxaliplatin induced neurotoxicity
Basic objectives2
Others
Basic objectives -Others
To evaluate the utility of nerve conduction velocity (NCV) and tuning fork for the oxaliplatin induced neurotoxicity
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Collation between NCV and oxaliplatin induced neurotoxicity
2. Collation between tuning fork and oxaliplatin induced neurotoxicity
3. Analyze the mechanism of oxaliplatin induced neurotoxicity
Key secondary outcomes
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
1.Nerve Conduction Velocity
2.tuning fork
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
1) Histologically confirmed colorectal cancer
2) No prior L-OHP administration
3) No peripheral neuropathy
4) Voluntary written informed consent
Key exclusion criteria
Metastasis to the CNS
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Hirashima |
Organization
Oita University, Faculty of Medecine
Division name
Medical Oncology
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu-city, Oita 879-5593, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Oita University, Faculty of Medecine
Division name
Medical Oncology
Zip code
Address
TEL
Homepage URL
hira@oita-u.ac.jp
Sponsor or person
Institute
Oita University, Faculty of Medecine
Institute
Department
Personal name
Funding Source
Organization
Oita University, Faculty of Medecine
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 09 | Month | 30 | 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
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 30 | Day |
Last modified on
| 2013 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005159
