UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017868 |
|---|---|
| Receipt number | R000020700 |
| Scientific Title | A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2016/12/11 11:14:45 |
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Basic information
Public title
A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity
Acronym
A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity
Scientific Title
A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity
Scientific Title:Acronym
A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity
Region
| Japan |
Condition
Condition
Those who have the possibility of developing chemotherapy-induced peripheral neurotoxicity
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Neurology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity of a point-of-care nerve conduction device (NC-stat) for the prediction of chemotherapy-induced peripheral neurotoxicity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the point-of-care nerve conduction studies of those who have the possibility of developing CIPN, with the time course and extent of CIPN of them
Key secondary outcomes
Correlation of the quantitative assesment of CIPN through the point-of-care nerve conduction device (NC-stat) with the quantitative assesment of CIPN through NCI-CTCAE ver4.0
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
To measure the sural nerve sensory conduction verocity (SNCV) and sensory action potential (SNAP) by the point-of-care nerve conduction device (NC-stat) at each chemotherapy cycle
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
Adult patients who are going to have chemotherapy including oxaliplatin, paclitaxel or docetaxel are included. All patients will have written informed consent.
Key exclusion criteria
Patients with pre-existing neuropathy, such as diabetes mellitus, alcoholic abuse or central nervous system metastasis are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Ando |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL
052-744-1903
yando@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ayumu Matsuoka |
Organization
Nagoya University Hospital
Division name
Department of Clinical Oncology and Chemotherapy
Zip code
Address
65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL
052-744-1903
Homepage URL
ayumu0611@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
Management Expenses Grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Novartis Pharma K.K
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 | 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
Date of protocol fixation
| 2015 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 27 | 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 | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020700
