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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016505
Receipt No. R000019165
Scientific Title A Validation Study of a Point-of-Care Nerve Conduction Device for the Quantitative Assesment of Chemotherapy-Induced Peripheral Neurotoxicity
Date of disclosure of the study information 2015/02/10
Last modified on 2016/02/26

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Basic information
Public title A Validation Study of a Point-of-Care Nerve Conduction Device for the Quantitative Assesment of Chemotherapy-Induced Peripheral Neurotoxicity
Acronym A Validation Study of a Point-of-Care Nerve Conduction Device for the Quantitative Assesment of Chemotherapy-Induced Peripheral Neurotoxicity
Scientific Title A Validation Study of a Point-of-Care Nerve Conduction Device for the Quantitative Assesment of Chemotherapy-Induced Peripheral Neurotoxicity
Scientific Title:Acronym A Validation Study of a Point-of-Care Nerve Conduction Device for the Quantitative Assesment of Chemotherapy-Induced Peripheral Neurotoxicity
Region
Japan

Condition
Condition Those who suffer from chemotherapy-induced peripheral neurotoxicity
Classification by specialty
Medicine in general Neurology
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 quantitative measurement 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 Validation of the point-of-care nerve conduction device for the objective, quantitative assessment of CIPN
Key secondary outcomes Correlation of the quantitative assesment of CIPN through the point-of-care nerve conduction device(NC-stat) with the qualitative 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)
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 have received chemotherapy and have suffred from CIPN (NCI-CTCAE ver4.0, Grade1, 2, 3) are included. All patients will have written informed consent.
Key exclusion criteria Patients with pre-existing neuropathy, diabetes mellitus, alcoholic abuse or central nervous system metastasis are excluded.
Target sample size 50

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, 466-8550, Japan
TEL 052-744-1903
Email 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, 466-8550, Japan
TEL 052-744-1903
Homepage URL
Email ayumu0611@med.nagoya-u.ac.jp

Sponsor
Institute Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital
Institute
Department

Funding Source
Organization Management Expenses Grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) OMRON HEALTHCARE CO.,Ltd.

IRB Contact (For public release)
Organization
Address
Tel
Email

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 02 Month 10 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
2015 Year 01 Month 28 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 12 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 10 Day
Last modified on
2016 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019165

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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