UMIN-CTR Clinical Trial

Basic information
Public title	Histological study of symptomatic neuroma
Acronym	Histological study of symptomatic neuroma
Scientific Title	Histological study of symptomatic neuroma
Scientific Title:Acronym	Histological study of symptomatic neuroma
Region	Japan

Condition
Condition	symptomatic neuroma
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine a histology of human symptomatic neuroma
Basic objectives2	Others
Basic objectives -Others	I examine a histology of human symptomatic neuroma and the relation of clinical symptom to reveal the clarify or statement of pain related axon and component cells.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain DETECT and correlation of the number of immunostaining axons.
Key secondary outcomes	1. The correlation of sensation and the number of immunostaining axon. 2. The correlation of skin temperature and the number of immunostaining axon. 3. The correlation of disease duration and the number of immunostaining axon. 4. The correlation of the detail of treatment and the number of immunostaining axon. 5. The correlation of cause of neuroma generation and the number of immunostaining axon.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Age over 20 years old. 2. The person obtained imformed consent adequately.
Key exclusion criteria	The patient whom principal investigator judged to be an inapptropriate.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Kadoya
Organization	Hokkaido University
Division name	Department of Orthopaedic Surgery,Faculty of Medicine and Graduate School of Medicine
Zip code	0608638
Address	Kita-ku Kita15 Nishi7 Sapporo Hokkaido
TEL	011-716-1161
Email	kadoya@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Matsui
Organization	Hokkaido University
Division name	Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine
Zip code	0608638
Address	Kita-ku Kita15 Nishi7 Sapporo Hokkaido
TEL	011-716-1161
Homepage URL
Email	yukimatsui0515@yahoo.co.jp

Sponsor
Institute	Hokkaido University
Institute
Department

Funding Source
Organization	The General Insurance Association of Japan
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	Hokkaido University Hospital Clinical Reseach and Medical Innovation Center
Address	Kita-ku Kita15 Nishi7 Sapporo Hokkaido
Tel	011-706-7061
Email	crsupport@huhp.hokudai.ac.jp

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	2018 Year 02 Month 27 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	2017 Year 12 Month 11 Day
Date of IRB	2017 Year 12 Month 11 Day
Anticipated trial start date	2017 Year 12 Month 11 Day
Last follow-up date	2022 Year 08 Month 31 Day
Date of closure to data entry	2022 Year 08 Month 31 Day
Date trial data considered complete	2022 Year 08 Month 31 Day
Date analysis concluded	2022 Year 08 Month 31 Day

Other
Other related information	finished.

Management information
Registered date	2018 Year 02 Month 27 Day
Last modified on	2022 Year 09 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035954