UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Validation Study of a Point-of-Care Nerve Conduction Device for the Prediction of Chemotherapy-induced Peripheral Neurotoxicity
Title of the study (Brief title)	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	Yuichi Ando
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65 Tsuruma-Cho, Showa-Ku, Nagoya, Japan
TEL	052-744-1903
Email	yando@med.nagoya-u.ac.jp

Public contact
Name of contact person	Ayumu Matsuoka
Organization	Nagoya University Hospital
Division name	Department of Clinical Oncology and Chemotherapy
Address	65 Tsuruma-Cho, Showa-Ku, Nagoya, 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	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Novartis Pharma K.K

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2015 Year 05 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020700