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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031497
Receipt No. R000035954
Scientific Title Histological study of symptomatic neuroma
Date of disclosure of the study information 2018/02/27
Last modified on 2018/02/27

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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
Middle name
Last name Ken Kadoya
Organization Hokkaido University
Division name Department of Orthopaedic Surgery,Faculty of Medicine and Graduate School of Medicine
Zip code
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
Middle name
Last name Yuki Matsui
Organization Hokkaido University
Division name Department of Orthopaedic Surgery, Faculty of Medicine and Graduate School of Medicine
Zip code
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
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
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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Now, I wait for the cases.

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


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

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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